CLINIMIX E

Manufacturer: Baxter Healthcare Company | Baxter Healthcare Corporation | Baxter SA
Effective date: 2021-04-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 17
Source: daily-update
Hydrated at: 2026-06-11 05:10:47

Label at a glance#

ProductCLINIMIX E

Active ingredientLEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, SODIUM ACETATE, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE

Label structure15 sections

Indications and uses

CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients.

Dosage and administration

• CLINIMIX E is available in a three port container configuration and a two port container configuration. • Three Port Container: the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container. • Two Port Container: the ports consist of one medication port and ...

Storage and handling

CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9 ). Table 9: CLINIMIX E Formulations (per 07-19-00-4607 and BE-30-03-649) After mixing, the product represents 1000 mL Code and NDC Number 2000 mL Code and NDC Number CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calciu...

Contacts and useful links#

PhoneLabel contact826 826 1320

PhoneLabel contact880 880 1035

PhoneLabel contact665 815 1070

PhoneLabel contact1-866-888-2472

PhoneFDA MedWatch1-800-FDA-1088

PhonePoison Help1-800-222-1222

Websitewww.fda.gov

www.fda.gov/medwatch

Websitewww.poison.org

www.poison.org

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 Preparation Prior to Administration

SPL UNCLASSIFIED SECTION

CLINIMIX E is available in a three port container configuration and a two port container configuration.
- Three Port Container: the ports consist of one medication port, one additive port and one outlet port. Additives can be introduced to the container through the medication port and lipids through the additive port on the three port container.
- Two Port Container: the ports consist of one medication port and one outlet port. Additives, including lipids, can be introduced to the container through the medication port on the two port container.
Tear protective overwrap at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating from inside the container. The amount of permeated water is insufficient to affect the solution significantly. If larger amounts of water are found, the container should be checked for tears or leaks.
Inspect the container prior to activation. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following:
- If the outlet or additive port protectors are damaged, detached, or not present, discard container as solution path sterility may be impaired.
- Check to ensure seal between chambers is intact, solutions are contained in separate chambers, and the content of the individual chambers is clear, colorless or slightly yellow. Discard if the seal is broken or if the solution is bright yellow or yellowish brown.
- Check for minute leaks by separately squeezing each chamber. If external leaks or leakage between the chambers are found, discard solution as sterility or stability may be impaired.
Lipids and/or additives can be introduced to the container after opening seal between chambers. Because additives may be incompatible, evaluate all additions to the plastic container for compatibility. Activate chambers of container prior to introduction of additives. Mix thoroughly when additives have been introduced. Supplemental medication may be added with a 19 to 22 gauge needle through the medication port.
Calcium and phosphate ratios must be considered. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium phosphate precipitates [see Warnings and Precautions (5.1)].
Inspect the container to ensure precipitates have not formed during the mixing or addition of additives. A slight yellow color does not alter the quality and efficacy of this product. If lipid has been added, ensure the emulsion has not separated. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the mixed emulsion. Discard the admixture if any of the above are observed.

2.2 Important Administration Instructions

SPL UNCLASSIFIED SECTION

Set the vent to the closed position on a vented intravenous administration set to prevent air embolism.
Use a dedicated line without any connections to avoid air embolism.
CLINIMIX E is for intravenous infusion only into a central or peripheral vein. The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter [see Warnings and Precautions (5.7)].
- For central vein infusion only: CLINIMIX E 4.25/10, 5/15, 5/20, 8/10, 8/14
- For central or peripheral vein infusion: CLINIMIX E 2.75/5 and 4.25/5
The solution should be inspected for precipitates before admixing, after admixing, and again before administration.
Use a 0.22 micron filter for administration of CLINIMIX E. If a lipid is also administered, use a 1.2 micron filter.
If lipid emulsion is added, do not use administration sets and lines that contain di-2-ethylhexyl phthalate (DEHP). Administration sets that contain polyvinyl chloride (PVC) components have DEHP as a plasticizer.
Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions such as CLINIMIX E via a Y-site. However, in patients other than neonates, ceftriaxone and CLINIMIX E may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid [see Contraindications (4), Warnings and Precautions (5.2)].

2.3 Instructions for Use

SPL UNCLASSIFIED SECTION

Open by tearing protective overwrap at slit and remove solution container. The two port container includes an oxygen-absorbing sachet. Discard the oxygen-absorbing sachet after removal from the overwrap.
To proceed with activation, the container should be at room temperature. Lay the room temperature container onto a flat surface. Grasp the container firmly on each side of the top of the container (Figure 1).
Starting from the top, using some pressure, slowly roll the container to open seal between chambers as shown in Figure 2. Do not pull or rip the seal apart. The seal must be completely opened towards the port side of the container. The upper section of the seal towards the hanger side can remain unbroken.
Mix the contents thoroughly by inverting the container upside down to ensure a homogenous admixture (Figure 3).
Once the container is mixed, check for leaks.
Make additions (if prescribed).
Because additives may be incompatible, evaluate all additions to the container for compatibility and stability of the resulting preparation. Consult with pharmacist, if available. Questions about compatibility may be directed to Baxter. If it is deemed advisable to introduce additives, use aseptic technique. For information on adding lipid emulsions see Dosage and Administration (2.4) .
1. Prepare medication port.
2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
3. Mix solution and medication thoroughly (Figure 3). For high density medication (high specific gravity), such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.
Inspect final solution for discoloration and particulate matter. Check for leaks.
8.Spike and hang container.
1. Suspend container from eyelet support.
2. Twist off protector from outlet port at bottom of container (Figure 4).
3. Attach administration set. Refer to complete directions accompanying set.
For single dose only. Discard unused portion.

Figures 1 – 4 (Three Port Container):

Figures 1 – 4 (Two Port Container):

Instructions on Storage

Storage After Removal of Overwrap:

Once removed from the protective overwrap, mixed (peel seal activated) or unmixed (peel seal intact), CLINIMIX E solutions may be stored under refrigeration for up to 9 days.

Storage Once any Additive is Added:

Use promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, less than 24 hours. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Any remaining mixture must be discarded.

Protect the activated parenteral nutrition solution from light.

2.4 Preparation and Addition of Lipid Emulsion

SPL UNCLASSIFIED SECTION

Three Port Container

Prior to adding lipid emulsion, mix amino acid and dextrose injection as shown in Figures 1-3.
Prepare lipid emulsion transfer set following instructions provided.
Attach transfer set to lipid emulsion container using aseptic technique.
Twist off protector on the additive port of the container.
Attach the transfer set to the exposed additive port.
Open clamp on transfer set.
After completing transfer, use appropriate plastic clamp or metal ferrule to seal off additive port tube.
Remove transfer set.
Mix contents of container thoroughly. Inspect final solution for discoloration and particulate matter. Check for leaks.

Two Port Container

Prior to adding lipid emulsion, mix amino acid and dextrose injection as shown in Figures 1-3.
Prepare lipid emulsion transfer set following instructions provided.
Attach transfer set to lipid emulsion container using aseptic technique.
Prepare medication port.
Using a 19 to 22 gauge needle, puncture resealable medication port.
Open clamp on transfer set and transfer lipid emulsion.
Remove needle.
Mix contents of container thoroughly. Inspect final solution for discoloration and particulate matter. Check for leaks.

Storage Once Lipids are Added:

Use promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, no longer than 24 hours. After removal from refrigeration, use promptly and complete the infusion within 24 hours. Any mixture remaining must be discarded.

2.5 Dosing Considerations

SPL UNCLASSIFIED SECTION

The dosage of CLINIMIX E should be individualized based on the patient’s clinical condition (ability to adequately metabolize amino acids and dextrose), body weight and nutritional/fluid requirements, as well as additional energy given orally/enterally to the patient. Prior to initiating CLINIMIX E the following patient information should be reviewed: all concomitant medications, gastrointestinal function and laboratory data such as electrolytes (including magnesium, calcium, and phosphorus), glucose, urea/creatinine, liver panel, complete blood count and triglyceride level (if adding lipid emulsion). Refer to the complete prescribing information of lipid emulsion for dosing information.
CLINIMIX E formulations have varying concentrations of protein, carbohydrate and a standard concentration of electrolytes; thus infusion rates to achieve requirements will vary. Protein, caloric, fluid and electrolyte requirements all need to be taken into consideration when determining individual patient dosage needs.
The dosage selection is based only on the recommended protein requirements. The maximum dextrose infusion rates and calorie and fluid requirements must also be considered when determining the clinically appropriate infusion rate for patients.
CLINIMIX E meets the total nutritional requirements for protein and dextrose in stable patients, and can be individualized to meet specific needs with the addition of nutrients.
Total daily fluid requirements can be met beyond the volume of amino acids solution by supplementing with non-carbohydrate or carbohydrate-containing electrolyte solutions. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.
Prior to administration of CLINIMIX E correct severe fluid, electrolyte and acid-base disorders.
Monitor levels of serum potassium during therapy. It may be necessary to add additional potassium to the CLINIMIX E admixture.
Lipid emulsion administration should be considered with prolonged use (more than 5 days) of CLINIMIX E in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free parenteral nutrition. See prescribing information of lipid emulsion.
The flow rate should be increased gradually. The flow rate must be adjusted taking into account the dose being administered, the daily volume intake, and the duration of the infusion.

2.6 Recommended Dosage in Adults

SPL UNCLASSIFIED SECTION

The recommended daily nutritional requirements for protein and dextrose compared to the amount of nutrition provided by CLINIMIX E are shown in Table 1.
As indicated on an individual basis, maintenance vitamins, additional electrolytes, trace elements and other components (including lipids) should be administered as required to prevent deficiencies and complications from developing.
The maximum infusion rates in adult patients are show in Table 2.

In addition to meeting protein needs, the administration rate should be governed, especially during the first few day of therapy, by the patient’s tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of blood glucose levels.

Table 1: Nutritional Comparison – Adult Patients
	Recommended CLINIMIX E Adult Dosage
	CLINIMIX E 2.75/5	CLINIMIX E 4.25/5	CLINIMIX E 4.25/10	CLINIMIX E 5/15	CLINIMIX E 5/20	CLINIMIX E 8/10	CLINIMIX E 8/14
Fluid (mL/kg/day)	29 to 40	19 to 40	19 to 40	16 to 40	16 to 40	10 to 25	10 to 25
Protein^*(g/kg/day) (Nitrogen g/kg/day)	0.8 to 1.1 (0.13 to 0.18)	0.8 to 1.7 (0.13 to 0.27)	0.8 to 1.7 (0.13 to 0.27)	0.8 to 2 (0.13 to 0.32)	0.8 to 2 (0.13 to 0.32)	0.8 to 2 (0.13 to 0.32)	0.8 to 2 (0.13 to 0.32)
Dextrose (g/kg/day)	1.45 to 2	0.95 to 2	1.9 to 4	2.4 to 6	3.2 to 8	1 to 2.5	1.4 to 3.5

* Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

Table 2: Maximum Infusion Rate in Adult Patients
		Maximum Infusion Rates in Adults Patients
		CLINIMIX E 2.75/5	CLINIMIX E 4.25/5	CLINIMIX E 4.25/10	CLINIMIX E 5/15	CLINIMIX E 5/20	CLINIMIX E 8/10	CLINIMIX E 8/14
Maximum Infusion Rate (mL/kg/hour)		3.6	2.4	2.4	1.67	1.25	1.3	1.3
Corresponding infusion rate	Amino Acid (g/kg/hour)	0.1^*	0.1	0.1	0.08	0.06	0.1	0.1
Corresponding infusion rate	Dextrose (g/kg/hour)	0.18	0.12	0.24	0.25	0.25	0.13	0.18

* Rate limiting factor

2.7 Dosage Modifications in Patients with Kidney Disease

SPL UNCLASSIFIED SECTION

Prior to administration, correct severe fluid or electrolyte imbalances. Closely monitor serum electrolyte levels and adjust the volume of CLINIMIX E administered as required [see Warnings and Precautions (5.11)].

Chronic kidney disease patients with less than nephrotic range proteinuria require 0.8 g of protein/kg/day. Chronic kidney disease patients with nephrotic range proteinuria require 0.8 g of protein/kg/day plus 1 g of protein for each gram of proteinuria. Patients needing dialysis should receive from 1.2 g of protein/kg/day up to a maximum of 2.5 g of protein/kg/day depending on the nutritional status and the dialysis modality. Serum electrolyte levels should be closely monitored. The CLINIMIX E dosage can be adjusted based on the severity of kidney disease, supplementing protein as indicated. If required, additional amino acids may be added to the CLINIMIX E container or infused separately. Compatibility of additions should be evaluated by a pharmacist and questions may be directed to Baxter.

2.8 Recommended Dosage in Pediatric Patients

SPL UNCLASSIFIED SECTION

The dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia [see Use in Specific Populations (8.4)]. Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants. The infusion rate and volume should be determined by the consulting physician experienced in pediatric intravenous fluid therapy.

In pediatric patients, CLINIMIX E is dosed on the basis of protein provided as amino acids. The recommended dosage, by age group is provided in Tables 3 - 6. Infusion rates are based on protein and do not take carbohydrates, fluid or electrolytes into consideration.

This product does not contain the amino acids cysteine and taurine, considered conditionally essential for neonates and infants. If possible, these amino acids should be added to this product if used in this pediatric population.

Table 3: Preterm and Term Infants Less than 1 Month of Age
	Recommended CLINIMIX E Dosage in Preterm and Term Infants Less than 1 Month of Age
	CLINIMIX E 2.75/5	CLINIMIX E 4.25/5	CLINIMIX E 4.25/10	CLINIMIX E 5/15	CLINIMIX E 5/20	CLINIMIX E 8/10	CLINIMIX E 8/14
Infusion Rate Range (mL/kg/hr)	4.5 to 6	2.9 to 3.9	2.9 to 3.9	2.5 to 3.3	2.5 to 3.3	1.6 to 2.1	1.6 to 2.1
Fluid (mL/kg/day)	108 to 144	70 to 94	70 to 94	60 to 79	60 to 79	38.4 to 50	38.4 to 50
Protein^*(g/kg/day) (Nitrogen g/kg/day)	3 to 4 (0.48 to 0.64)	3 to 4 (0.48 to 0.64)	3 to 4 (0.48 to 0.64)	3 to 4 (0.48 to 0.64)	3 to 4 (0.48 to 0.64)	3 to 4 (0.48 to 0.64)	3 to 4 (0.48 to 0.64)
Dextrose (g/kg/day)	5.4 to 7.2	3.5 to 4.7	7 to 9.4	9 to 11.9	12 to 15.8	3.8 to 5	5.4 to 7

* Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

Table 4: Pediatric Patients 1 Month to Less than 1 Year of Age
	Recommended CLINIMIX E Dosage in Pediatric Patients 1 Month to Less than 1 Year of Age
	CLINIMIX E 2.75/5	CLINIMIX E 4.25/5	CLINIMIX E 4.25/10	CLINIMIX E 5/15	CLINIMIX E 5/20	CLINIMIX E 8/10	CLINIMIX E 8/14
Infusion Rate Range (mL/kg/hr)	3 to 4.5	2 to 2.9	2 to 2.9	1.7 to 2.5	1.7 to 2.5	1 to 1.6	1 to 1.6
Fluid (mL/kg/day)	72 to 108	48 to 70	48 to 70	41 to 60	41 to 60	24 to 38.4	24 to 38.4
Protein^*(g/kg/day) (Nitrogen g/kg/day)	2 to 3 (0.32 to 0.48)	2 to 3 (0.32 to 0.48)	2 to 3 (0.32 to 0.48)	2 to 3 (0.32 to 0.48)	2 to 3 (0.32 to 0.48)	2 to 3 (0.32 to 0.48)	2 to 3 (0.32 to 0.48)
Dextrose (g/kg/day)	3.6 to 5.4	2.4 to 3.5	4.8 to 7	6.1 to 9	8.2 to 12	2.4 to 3.8	3.4 to 5.4

* Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

Table 5: Pediatric Patients 1 Year to Less than 11 Years of Age
	Recommended CLINIMIX E Dosage in Pediatric Patients 1 Year to Less than 11 Years of Age
	CLINIMIX E 2.75/5	CLINIMIX E 4.25/5	CLINIMIX E 4.25/10	CLINIMIX E 5/15	CLINIMIX E 5/20	CLINIMIX E 8/10	CLINIMIX E 8/14
Infusion Rate Range (mL/kg/hr)	1.5 to 3	1 to 2	1 to 2	0.8 to 1.7	0.8 to 1.7	0.5 to 1	0.5 to 1
Fluid (mL/kg/day)	36 to 72	24 to 48	24 to 48	19 to 41	19 to 41	12 to 24	12 to 24
Protein^*(g/kg/day) (Nitrogen g/kg/day)	1 to 2 (0.16 to 0.32)	1 to 2 (0.16 to 0.32)	1 to 2 (0.16 to 0.32)	1 to 2 (0.16 to 0.32)	1 to 2 (0.16 to 0.32)	1 to 2 (0.16 to 0.32)	1 to 2 (0.16 to 0.32)
Dextrose (g/kg/day)	1.8 to 3.6	1.2 to 2.4	2.4 to 4.8	2.9 to 6.1	3.8 to 8.2	1.2 to 2.4	1.7 to 3.4

* Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

Table 6: Pediatric Patients 11 Years to 17 Years of Age
	Recommended CLINIMIX E Dosage in Pediatric Patients 11 Years to 17 Years of Age
	CLINIMIX E 2.75/5	CLINIMIX E 4.25/5	CLINIMIX E 4.25/10	CLINIMIX E 5/15	CLINIMIX E 5/20	CLINIMIX E 8/10	CLINIMIX E 8/14
Infusion Rate Range (mL/kg/hr)	1.2 to 2.3	0.8 to 1.5	0.8 to 1.5	0.7 to 1.3	0.7 to 1.3	0.4 to 0.8	0.4 to 0.8
Fluid (mL/kg/day)	29 to 55	19 to 36	19 to 36	17 to 31	17 to 31	9.6 to 19.2	9.6 to 19.2
Protein^*(g/kg/day) (Nitrogen g/kg/day)	0.8 to 1.5 (0.13 to 0.24)	0.8 to 1.5 (0.13 to 0.24)	0.8 to 1.5 (0.13 to 0.24)	0.8 to 1.5 (0.13 to 0.24)	0.8 to 1.5 (0.13 to 0.24)	0.8 to 1.5 (0.13 to 0.24)	0.8 to 1.5 (0.13 to 0.24)
Dextrose (g/kg/day)	1.4 to 2.8	1 to 1.8	1.9 to 3.6	2.5 to 4.7	3.4 to 6.2	1 to 1.9	1.4 to 2.7

* Protein is provided as amino acids. When infused intravenously amino acids are metabolized and utilized as the building blocks of protein.

2.9 Discontinuation of CLINIMIX E injection

SPL UNCLASSIFIED SECTION

To reduce the risk of hypoglycemia after discontinuation, a gradual decrease in flow rate in the last hour of infusion should be considered.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

CLINIMIX E injection is available in 1000 mL and 2000 mL dual chamber containers. The individual chambers contain essential and nonessential amino acids with electrolytes and dextrose with calcium. Table 7 describes the individual components of CLINIMIX E.

Table 7: INGREDIENTS PER 100mL OF CLINIMIX E
Strength of CLINIMIX E		CLINIMIX E 2.75/5 sulfite‑free (2.75% Amino Acid in 5% Dextrose) Injection	CLINIMIX E 4.25/5 sulfite‑free (4.25% Amino Acid in 5% Dextrose) Injection	CLINIMIX E 4.25/10 sulfite‑free (4.25% Amino Acid in 10% Dextrose) Injection	CLINIMIX E 5/15 sulfite‑free (5% Amino Acid in 15% Dextrose) Injection	CLINIMIX 5/20 sulfite‑free (5% Amino Acid in 20% Dextrose) Injection	CLINIMIX E 8/10 sulfite‑free (8% Amino Acid in 10% Dextrose) Injection	CLINIMIX E 8/14 sulfite‑free (8% Amino Acid in 14% Dextrose) Injection
	Dextrose Hydrous, USP (g/100 mL)	5	5	10	15	20	10	14
	Amino Acids (g/100 mL)	2.75	4.25	4.25	5	5	8	8
	Total Nitrogen (mg/100 mL)	454	702	702	826	826	1320	1320
Essential Amino Acids (mg/100 mL)	Leucine	201	311	311	365	365	584	584
	Isoleucine	165	255	255	300	300	480	480
	Valine	160	247	247	290	290	464	464
	Lysine (added as the hydrochloride salt)	159	247	247	290	290	464	464
	Phenylalanine	154	238	238	280	280	448	448
	Histidine	132	204	204	240	240	384	384
	Threonine	116	179	179	210	210	336	336
	Methionine	110	170	170	200	200	320	320
	Tryptophan	50	77	77	90	90	144	144
Nonessential Amino Acids (mg/100 mL)	Alanine	570	880	880	1035	1035	1656	1656
	Arginine	316	489	489	575	575	920	920
	Glycine	283	438	438	515	515	824	824
	Proline	187	289	289	340	340	544	544
	Serine	138	213	213	250	250	400	400
	Tyrosine	11	17	17	20	20	32	32
Electrolytes (mg/100 mL)	Sodium Acetate Trihydrate, USP	217	297	297	340	340	0	0
	Dibasic Potassium Phosphate, USP	261	261	261	261	261	261	261
	Sodium Chloride, USP	112	77	77	59	59	205	205
	Magnesium Chloride, USP	51	51	51	51	51	51	51
	Calcium Chloride Dihydrate, USP	33	33	33	33	33	33	33
Electrolyte Profile (mEq/L)^*	Sodium	35	35	35	35	35	35	35
	Potassium	30	30	30	30	30	30	30
	Magnesium	5	5	5	5	5	5	5
	Calcium	4.5 (2.2 mmol/L)	4.5 (2.2 mmol/L)	4.5 (2.2 mmol/L)	4.5 (2.2 mmol/L)	4.5 (2.2 mmol/L)	4.5 (2.2 mmol/L)	4.5 (2.2 mmol/L)
	Acetate^†	51	70	70	80	80	83	83
	Chloride^‡	39	39	39	39	39	76	76
	Phosphate (as HPO₄ ⁼)	30 (15 mmol/L)	30 (15 mmol/L)	30 (15 mmol/L)	30 (15 mmol/L)	30 (15 mmol/L)	30 (15 mmol/L)	30 (15 mmol/L)
	pH^§ (Range)	6.0 (4.5 to 7.0)	6.0 (4.5 to 7.0)	6.0 (4.5 to 7.0)	6.0 (4.5 to 7.0)	6.0 (4.5 to 7.0)	6.0 (4.5 to 7.0)	6.0 (4.5 to 7.0)
	Osmolarity (mOsmol/L) (calc)	665	815	1070	1395	1650	1450	1650
Caloric Content (kcal/L)	From Dextrose	170	170	340	510	680	343	477
	From Amino Acids	110	170	170	200	200	320	320
	TOTAL (Dextrose and Amino Acids)	280	340	510	710	880	663	797

* Balanced by ions from amino acids.

† Derived from glacial acetic acid (for pH adjustment) and sodium acetate.

‡ Contributed by calcium chloride, lysine hydrochloride, magnesium chloride, sodium chloride, and hydrochloric acid.

§ pH of sulfite-free amino acid injection with electrolytes in the outlet port chamber was adjusted with glacial acetic acid and pH of dextrose injection port chamber was adjusted with hydrochloric acid.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

The use of CLINIMIX E is contraindicated in:
Neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.2), Use in Specific Populations (8.4)].
Patients with known hypersensitivity to one or more amino acids or dextrose [see Warnings and Precautions (5.3)].
Patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications.
Patients with pulmonary edema or acidosis due to low cardiac output.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates

SPL UNCLASSIFIED SECTION

Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. In some cases, fatal outcomes due to pulmonary embolism have occurred. Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. Excessive addition of calcium and phosphate increases the risk of the formation of calcium phosphate precipitates. Precipitates have been reported even in the absence of phosphate salt in the solution. Precipitation following passage through an in-line filter and suspected in vivo precipitate formation has also been reported. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration (2.1, 2.2, 2.3, 2.4)], the infusion set and catheter should also periodically be checked for precipitates.

5.2 Precipitation with Ceftriaxone

SPL UNCLASSIFIED SECTION

Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with calcium-containing parenteral nutrition solutions, such as CLINIMIX E, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site.

Deaths have occurred in neonates (less than 28 days of age) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used. CLINIMIX E is contraindicated in neonates receiving ceftriaxone [see Contraindications (4),Use in Specific Populations (8.4)].

In patients older than 28 days (including adults), ceftriaxone and CLINIMIX E may be administered sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

5.3 Hypersensitivity Reactions

SPL UNCLASSIFIED SECTION

Hypersensitivity/infusion reactions including anaphylaxis have been reported with CLINIMIX E. Stop infusion immediately and treat patient accordingly if any signs or symptoms of a hypersensitivity reaction develop. Signs or symptoms may include: hypotension, hypertension, peripheral cyanosis, tachycardia, dyspnea, vomiting, nausea, urticaria, rash, pruritus, erythema, hyperhidrosis, pyrexia, and chills.

5.4 Risk of Infections

SPL UNCLASSIFIED SECTION

Patients who require parenteral nutrition are at high risk of infections because the nutritional components of these solutions can support microbial growth. Infection and sepsis may also occur as a result of the use of intravenous catheters to administer parenteral nutrition.

The risk of infection is increased in patients with malnutrition-associated immunosuppression, hyperglycemia exacerbated by dextrose infusion, long-term use and poor maintenance of intravenous catheters, or immunosuppressive effects of other concomitant conditions, drugs, or other components of the parenteral formulation (e.g., lipid emulsion).

To decrease the risk of infection, ensure aseptic technique in catheter placement and maintenance, as well as aseptic technique in the preparation and administration of the nutritional formula.

Monitor for signs and symptoms (including fever and chills) of early infections, including laboratory test results (including leukocytosis and hyperglycemia) and frequent checks of the parenteral access device and insertion site for edema, redness and discharge.

5.5 Refeeding Syndrome

SPL UNCLASSIFIED SECTION

Refeeding severely undernourished patients may result in refeeding syndrome, characterized by the intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic. Thiamine deficiency and fluid retention may also develop. To prevent these complications, monitor severely undernourished patients and slowly increase nutrient intakes.

5.6 Hyperglycemia or Hyperosmolar Hyperglycemic State

SPL UNCLASSIFIED SECTION

When using CLINIMIX E in patients with diabetes mellitus, impaired glucose tolerance may worsen hyperglycemia. Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death. Patients with dehydration, resulting in a transient reduction in glomerular filtration rate and pre-renal azotemia, may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels while administering CLINIMIX E. Insulin may be administered or adjusted to maintain optimal blood glucose levels during CLINIMIX E administration.

5.7 Vein Damage and Thrombosis

SPL UNCLASSIFIED SECTION

Solutions with osmolarity of 900 mOsm/L or greater must be infused through a central catheter. CLINIMIX E solutions containing more than 5% dextrose have an osmolarity greater than or equal to 900 mOsm/L. CLINIMIX E 4.25/10, 5/15, 5/20, 8/10 and 8/14 are indicated for administration into a central vein only, such as the superior vena cava [see Dosage and Administration (2.2)]. The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis.

CLINIMIX E 2.75/5 and 4.25/5 are indicated for peripheral administration, or may be infused into a central vein [see Dosage and Administration (2.2)]. The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops.

5.8 Hepatobiliary Disorders

SPL UNCLASSIFIED SECTION

Hepatobiliary disorders are known to develop in some patients without preexisting liver disease who receive parenteral nutrition, including cholecystitis, cholelithiasis, cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure. The etiology of these disorders is thought to be multifactorial and may differ between patients.

Increase in blood ammonia levels and hyperammonemia may occur in patients receiving amino acid solutions. In some patients this may indicate hepatic insufficiency or the presence of an inborn error of amino acid metabolism [see Contraindications (4)].

Monitor liver function parameters and ammonia levels. Patients developing signs of hepatobiliary disorders should be assessed early by a clinician knowledgeable in liver diseases in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.

5.9 Aluminum Toxicity

SPL UNCLASSIFIED SECTION

CLINIMIX E contains no more than 25 mcg/L of aluminum. The aluminum contained in CLINIMIX E may reach toxic levels with prolonged administration in patients with impaired kidney function.

Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Patients with impaired kidney function, including preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day, accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

5.10 Risk of Parenteral Nutrition Associated Liver Disease

SPL UNCLASSIFIED SECTION

Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis. The exact etiology is unknown and is likely multifactorial. If CLINIMIX E treated patients develop liver test abnormalities consider discontinuation or dosage reduction.

5.11 Electrolyte Imbalance and Fluid Overload

SPL UNCLASSIFIED SECTION

Patients with abnormal renal function due to pre-renal azotemia, renal obstruction, or intrinsic kidney disease may be at increased risk of electrolyte and fluid volume imbalance. Patients with cardiac insufficiency due to left ventricular systolic dysfunction are susceptible to excess fluid accumulation. Use CLINIMIX E with caution in patients with cardiac insufficiency or kidney disease. CLINIMIX E dosage may require adjustment with specific attention to fluid, protein, and electrolyte content in these patients.

Monitor renal function parameters. Patients developing signs of kidney disease should be assessed early by a clinician knowledgeable in kidney disease in order to determine the appropriate CLINIMIX E dosage and other treatment options.

5.12 Monitoring/Laboratory Tests

SPL UNCLASSIFIED SECTION

Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment. In situations of severely elevated electrolyte levels, stop CLINIMIX E until levels have been corrected.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.

Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1)]
Death in neonates due to calcium-ceftriaxone precipitates [see Warnings and Precautions (5.2)]
Hypersensitivity reactions [see Warnings and Precautions (5.3)]
Risk of Infections [see Warnings and Precautions (5.4)]
Refeeding syndrome [see Warnings and Precautions (5.5)]
Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.6)]
Vein damage and thrombosis [see Warnings and Precautions (5.7)]
Hepatobiliary disorders [see Warnings and Precautions (5.8)]
Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10)]
Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11)]

The following adverse reactions from voluntary reports or clinical studies have been reported with CLINIMIX E. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Diuresis
Extravasation
Glycosuria
Hyperglycemia
Hyperosmolar coma

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

7.1 Drugs that Can Cause Hyperkalemia

SPL UNCLASSIFIED SECTION

Because of its potassium content, CLINIMIX E should be administered with caution in patients treated with agents or products that can cause hyperkalemia or increase the risk of hyperkalemia, such as potassium sparing diuretics (amiloride, spironolactone, triamterene), with ACE inhibitors, angiotensin II receptor antagonists, or the immunosuppressants tacrolimus and cyclosporine.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

Risk Summary

SPL UNCLASSIFIED SECTION

There are no adequate or well-controlled studies in pregnant women with CLINIMIX E. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX E can cause fetal harm when administered to a pregnant woman.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Clinical Considerations

SPL UNCLASSIFIED SECTION

Disease-Associated Maternal and/or Embryo-Fetal Risk

Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutrition where nutritional requirements cannot be fulfilled by the enteral route because of the risks to the fetus associated with severe malnutrition, such as preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality.

8.2 Lactation

LACTATION SECTION

Risk Summary

SPL UNCLASSIFIED SECTION

It is not known whether CLINIMIX E is present in human milk. There are no data on the effects of CLINIMIX E on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLINIMIX E and any potential adverse effects on the breastfed child from CLINIMIX E or from the underlying maternal condition.

8.4 Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness of CLINIMIX E in pediatric patients have not been established by adequate and well-controlled studies. Use of dextrose, amino acid infusions and electrolytes in pediatric patients is based on clinical practice [see Dosage and Administration (2.8)].

Deaths have occurred in neonates (28 days of age or younger) who received concomitant intravenous calcium-containing solutions with ceftriaxone resulting from calcium-ceftriaxone precipitates in the lungs and kidneys, even when separate infusion lines were used. CLINIMIX E is contraindicated in neonates receiving ceftriaxone [see Contraindications (4), Warnings and Precautions (5.2)].

Newborns, especially those born premature and with low birth weight, are at increased risk of developing hypo – or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Hypoglycemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycemia has been associated with intraventricular hemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

Because of immature renal function, preterm infants receiving prolonged treatment with CLINIMIX E, may be at risk of aluminum toxicity [see Warnings and Precautions (5.9)].

Patients, including pediatric patients, may be at risk for Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10)].

Hyperammonemia is of special significance in infants (birth to two years). This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants [see Warnings and Precautions (5.8)].

8.5 Geriatric Use

GERIATRIC USE SECTION

Clinical studies of CLINIMIX E did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

10 OVERDOSAGE

OVERDOSAGE SECTION

An increased infusion rate of CLINIMIX E can cause hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance [see Warnings and Precautions (5.6, 5.11)].

Severe hyperglycemia and severe dilutional hyponatremia, and their complications, can be fatal.

Discontinue infusion and institute appropriate corrective measures in the event of overhydration or solute overload during therapy, with particular attention to respiratory and cardiovascular systems.

For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

11 DESCRIPTION

DESCRIPTION SECTION

CLINIMIX E sulfite-free (amino acids with electrolytes in dextrose with calcium) injection for intravenous use consists of sterile, nonpyrogenic, hypertonic solutions in a dual chamber container.

The outlet port chamber contains essential and nonessential amino acids with electrolytes. The formulas for the individual electrolytes and amino acids are provided in Table 8 .

Table 8: Formulas for Electrolytes and Amino Acids
Electrolytes
Sodium Acetate	C₂H₃NaO₂•3H₂O
Potassium Phosphate, dibasic	K₂HPO₄
Magnesium Chloride	MgCl₂•6H₂O
Sodium Chloride	NaCl
Essential Amino Acids
Leucine	(CH₃)₂ CHCH₂CH (NH₂) COOH
Isoleucine	CH₃CH₂CH (CH₃) CH (NH₂) COOH
Valine	(CH₃)₂ CHCH (NH₂) COOH
Lysine (added as the hydrochloride salt)	H₂N (CH₂)₄ CH (NH₂) COOH
Phenylalanine	(C₆H₅) CH₂ CH (NH₂) COOH
Histidine	(C₃H₃N₂) CH₂CH (NH₂) COOH
Threonine	CH₃CH (OH) CH (NH₂) COO
Methionine	CH₃S (CH₂)2 CH (NH₂) COOH
Tryptophan	(C₈H₆N) CH₂ CH (NH₂) COOH
Nonessential Amino Acids
Alanine	CH₃CH (NH₂) COOH
Arginine	H₂NC (NH) NH (CH₂)3 CH (NH₂) COOH
Glycine	H₂NCH₂COOH
Proline	[(CH₂)₃ NH CH] COOH
Serine	HOCH₂CH (NH₂) COOH
Tyrosine	[C₆H₄ (OH)] CH₂CH (NH₂) COOH

The injection port chamber contains dextrose with calcium. The formula for Calcium Chloride is: CaCl₂•2H₂O. Dextrose, USP, is chemically designated D-glucose, monohydrate (C₆H₁₂O₆ • H₂O) and has the following structure:

Dextrose is derived from corn.

See Table 7 for composition, pH, osmolarity, ionic concentration and caloric content of the admixed product [see Dosage Forms and Strengths (3)].

The dual chamber container is a lipid-compatible plastic container (PL 2401 Plastic).

CLINIMIX E contains no more than 25 mcg/L of aluminum.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

SPL UNCLASSIFIED SECTION

CLINIMIX E is used as a supplement of nutrition in patients, providing macronutrients (amino acids and dextrose) and micronutrients (electrolytes) parenterally.

The amino acids provide the structural units that make up proteins and are used to synthesize proteins and other biomolecules or are oxidized to urea and carbon dioxide as a source of energy.

The administered dextrose is oxidized to carbon dioxide and water, yielding energy.

12.3 Pharmacokinetics

SPL UNCLASSIFIED SECTION

The disposition of infused amino acids, dextrose, and electrolytes are essentially the same as those absorbed from ordinary food.

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9).

Table 9: CLINIMIX E Formulations (per 07-19-00-4607 and BE-30-03-649)
After mixing, the product represents	1000 mL Code and NDC Number	2000 mL Code and NDC Number
CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection	Code 2B7735 NDC 0338-1142-03
CLINIMIX E 4.25/5 sulfite-free (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection	Code 2B7737 NDC 0338-1144-03	Code 2B7716 NDC 0338-1113-04
CLINIMIX E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection	Code 2B7738 NDC 0338-1145-03	Code 2B7717 NDC 0338-1115-04
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection	Code 2B7740 NDC 0338-1147-03	Code 2B7721 NDC 0338-1123-04
CLINIMIX E 5/20 sulfite-free (5% Amino Acid with Electrolytes in 20% Dextrose with Calcium) Injection	Code 2B7741 NDC 0338-1148-03	Code 2B7722 NDC 0338-1125-04
CLINIMIX E 8/10 sulfite-free (8% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection	Code EADB9943 NDC 0338-210-06	Code EADB9945 NDC 0338-0214-04
CLINIMIX E 8/14 sulfite-free (8% Amino Acid with Electrolytes in 14% Dextrose with Calcium) Injection	Code EADB9963 NDC 0338-0202-06	Code EADB9965 NDC 0338-0206-04

Table 9: CLINIMIX E Formulations (per BE-30-04-048)
After mixing, the product represents	1000 mL Code and NDC Number	2000 mL Code and NDC Number
CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection	Code 2B7735L NDC 0338-7020-01	/
CLINIMIX E 4.25/5 sulfite-free (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection	Code 2B7737L NDC 0338-7022-01	Code 2B7716L NDC 0338-7024-01
CLINIMIX E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection	Code 2B7738L NDC 0338-7026-01	Code 2B7717L NDC 0338-7028-01
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection	Code 2B7740L NDC 0338-7030-01	Code 2B7721L NDC 0338-7032-01
CLINIMIX E 5/20 sulfite-free (5% Amino Acid with Electrolytes in 20% Dextrose with Calcium) Injection	Code 2B7741L NDC 0338-7034-01	Code 2B7722L NDC 0338-7036-01
CLINIMIX E 8/10 sulfite-free (8% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection	Code EADB9943 NDC 0338-0210-06	Code EADB9945 NDC 0338-0214-04
CLINIMIX E 8/14 sulfite-free (8% Amino Acid with Electrolytes in 14% Dextrose with Calcium) Injection	Code EADB9963 NDC 0338-0202-06	Code EADB9965 NDC 0338-0206-04

Minimize exposure of CLINIMIX E to heat and avoid excessive heat.

Protect from freezing.

Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F).

Refrigerated storage is limited to 9 days once the protective overwrap has been opened.

Do not use if the protective overwrap has been previously opened or damaged.

For storage of admixed solutions see Dosage and Administration (2.3, 2.4).

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Inform patients, caregivers, or home healthcare providers of the following risks of CLINIMIX E:

Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1)]
Death in neonates due to calcium-ceftriaxone precipitates [see Warnings and Precautions (5.2)]
Hypersensitivity reactions [see Warnings and Precautions (5.3)]
Risk of Infections [see Warnings and Precautions (5.4)]
Refeeding syndrome [see Warnings and Precautions (5.5)]
Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.6)]
Vein damage and thrombosis [see Warnings and Precautions (5.7)]
Hepatobiliary disorders [see Warnings and Precautions (5.8)]
Aluminum toxicity [see Warnings and Precautions (5.9)]
Parenteral Nutrition Associated Liver Disease (PNALD) [see Warnings and Precautions (5.10)]
Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.11)]

SPL UNCLASSIFIED SECTION

Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Baxter and Clinimix E are registered trademarks of Baxter International Inc.
07-19-00-4607 [Applies to Baxter Healthcare Corporation, Jayuya – Puerto Rico manufacturing plant]
BE-30-03-649 [Applies to Baxter SA, Lessines – Belgium manufacturing plant for Clinimix E 8/20 and Clinimix E 8/14]
BE-30-04-048 [Applies to Baxter SA, Lessines – Belgium manufacturing plant for the other Clinimix E formulations]

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOT EXP

2B7735 NDC 0338-1142-03

CLINIMIX E
WITH ELECTROLYTES 2.75/5

SULFITE-FREE
(2.75% Amino Acids
with Electrolytes in
5% Dextrose with
Calcium) Injection

500 mL INJECTION PORT CHAMBER
10% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
5.5% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY
AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

DEXTROSE HYDROUS USP 5 g
ESSENTIAL AMINO ACIDS
LEUCINE 201 mg
ISOLEUCINE 165 mg
VALINE 160 mg
LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 159 mg
PHENYLALANINE 154 mg
HISTIDINE 132 mg
THREONINE 116 mg
METHIONINE 110 mg
TRYPTOPHAN 50 mg
NONESSENTIAL AMINO ACIDS
ALANINE 570 mg
ARGININE 316 mg
GLYCINE 283 mg
PROLINE 187 mg
SERINE 138 mg
TYROSINE 11 mg
ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 217 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 112 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg
mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 51
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)
BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
STERILE
SINGLE DOSE CONTAINER

ROOM TEMPERATURE (25°C/77°F)
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US
MADE IN USA

LOT EXP

2B7737 NDC 0338-1144-03

CLINIMIX E
WITH ELECTROLYTES 4.25/5

SULFITE-FREE
(4.25% Amino Acid
with Electrolytes in
5% Dextrose with
Calcium) Injection

500 mL INJECTION PORT CHAMBER
10% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
8.5% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

DEXTROSE HYDROUS USP 5 g
ESSENTIAL AMINO ACIDS
LEUCINE 311 mg
ISOLEUCINE 255 mg
VALINE 247 mg
LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 247 mg
PHENYLALANINE 238 mg
HISTIDINE 204 mg
THREONINE 179 mg
METHIONINE 170 mg
TRYPTOPHAN 77 mg
NONESSENTIAL AMINO ACIDS
ALANINE 880 mg
ARGININE 489 mg
GLYCINE 438 mg
PROLINE 289 mg
SERINE 213 mg
TYROSINE 17 mg
ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 297 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 77 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg
mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 70
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)
BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
STERILE
SINGLE DOSE CONTAINER
ROOM TEMPERATURE (25°C/77°F)
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US
MADE IN USA

LOT EXP

2B7716 NDC 0338-1113-04

CLINIMIX E
WITH ELECTROLYTES 4.25/5

SULFITE-FREE
(4.25% Amino Acid
with Electrolytes in
5% Dextrose with
Calcium) Injection

1000 mL INJECTION PORT CHAMBER
10% Dextrose Injection with Calcium

1000 mL OUTLET PORT CHAMBER
8.5% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

ROOM TEMPERATURE (25°C/77°F)

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US

LOT EXP

2B7738 NDC 0338-1145-03

CLINIMIX E
WITH ELECTROLYTES 4.25/10

SULFITE-FREE
(4.25% Amino Acid
with Electrolytes in
10% Dextrose with
Calcium) Injection

500 mL INJECTION PORT CHAMBER
20% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
8.5% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

DEXTROSE HYDROUS USP 10 g
ESSENTIAL AMINO ACIDS
LEUCINE 311 mg
ISOLEUCINE 255 mg
VALINE 247 mg
LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 247 mg
PHENYLALANINE 238 mg
HISTIDINE 204 mg
THREONINE 179 mg
METHIONINE 170 mg
TRYPTOPHAN 77 mg
NONESSENTIAL AMINO ACIDS
ALANINE 880 mg
ARGININE 489 mg
GLYCINE 438 mg
PROLINE 289 mg
SERINE 213 mg
TYROSINE 17 mg
ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 297 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 77 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg
mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 70
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)
BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
STERILE
SINGLE DOSE CONTAINER
ROOM TEMPERATURE (25°C/77°F)
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US

LOT EXP

2B7717 NDC 0338-1115-04

CLINIMIX E
WITH ELECTROLYTES 4.25/10

SULFITE-FREE
(4.25% Amino Acid
with Electrolytes in
10% Dextrose with
Calcium) Injection

CENTRAL LINE INFUSION ONLY

1000 mL INJECTION PORT CHAMBER
20% Dextrose Injection with Calcium

1000 mL OUTLET PORT CHAMBER
8.5% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

ROOM TEMPERATURE (25°C/77°F)

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US

LOT EXP

2B7740 NDC 0338-1147-03

CLINIMIX E
WITH ELECTROLYTES 5/15

SULFITE-FREE
(5% Amino Acid
with Electrolytes in
15% Dextrose with
Calcium) Injection

CENTRAL LINE INFUSION ONLY

500 mL INJECTION PORT CHAMBER
30% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
10% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

DEXTROSE HYDROUS USP 15 g
ESSENTIAL AMINO ACIDS
LEUCINE 365 mg
ISOLEUCINE 300 mg
VALINE 290 mg
LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 290 mg
PHENYLALANINE 280 mg
HISTIDINE 240 mg
THREONINE 210 mg
METHIONINE 200 mg
TRYPTOPHAN 90 mg
NONESSENTIAL AMINO ACIDS
ALANINE 1035 mg
ARGININE 575 mg
GLYCINE 515 mg
PROLINE 340 mg
SERINE 250 mg
TYROSINE 20 mg
ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 340 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 59 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg
mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 80
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)
BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
STERILE
SINGLE DOSE CONTAINER

ROOM TEMPERATURE (25°C/77°F)
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US

Container Label

LOT EXP

2B7721 NDC 0338-1123-04

CLINIMIX E
WITH ELECTROLYTES 5/15

SULFITE-FREE
(5% Amino Acid
with Electrolytes in
15% Dextrose with
Calcium) Injection

1000 mL INJECTION PORT CHAMBER
30% Dextrose Injection with Calcium

1000 mL OUTLET PORT CHAMBER
10% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

ROOM TEMPERATURE (25°C/77°F)

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US

LOT EXP

2B7741 NDC 0338-1148-03

CLINIMIX E
WITH ELECTROLYTES 5/20

SULFITE-FREE
(5% Amino Acid
with Electrolytes in
20% Dextrose with
Calcium) Injection

500 mL INJECTION PORT CHAMBER
40% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
10% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

DEXTROSE HYDROUS USP 20 g
ESSENTIAL AMINO ACIDS
LEUCINE 365 mg
ISOLEUCINE 300 mg
VALINE 290 mg
LYSINE (ADDED AS THE HYDROCHLORIDE SALT) 290 mg
PHENYLALANINE 280 mg
HISTIDINE 240 mg
THREONINE 210 mg
METHIONINE 200 mg
TRYPTOPHAN 90 mg
NONESSENTIAL AMINO ACIDS
ALANINE 1035 mg
ARGININE 575 mg
GLYCINE 515 mg
PROLINE 340 mg
SERINE 250 mg
TYROSINE 20 mg
ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 340 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 59 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg
mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 80
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)
BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
STERILE
SINGLE DOSE CONTAINER
ROOM TEMPERATURE (25°C/77°F)
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US

LOT EXP

2B7722 NDC 0338-1125-04

CLINIMIX E
WITH ELECTROLYTES 5/20

SULFITE-FREE
(5% Amino Acid
with Electrolytes in
20% Dextrose with
Calcium) Injection

1000 mL INJECTION PORT CHAMBER
40% Dextrose Injection with Calcium

1000 mL OUTLET PORT CHAMBER
10% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION

ROOM TEMPERATURE (25°C/77°F)

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 US

EADB9963

1000 mL

NDC 0338-0202-01

CLINIMIX E
WITH ELECTROLYTES 8/14

SULFITE-FREE
(8% Amino Acids
with Electrolytes in
14% Dextrose with
Calcium) Injection

CENTRAL LINE INFUSION ONLY

360 mL INJECTION PORT CHAMBER
39% Dextrose Injection with Calcium

640 mL OUTLET PORT CHAMBER

12.5% Amino Acid Injection

with Electrolytes

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

2000 mL

SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

EXP

CONTENTS OF EACH 100 mL
OF THE ADMIXED INJECTION
DEXTROSE HYDROUS USP 14 g
ESSENTIAL AMINO ACIDS
LEUCINE 584 mg
ISOLEUCINE 480 mg
VALINE 464 mg
LYSINE (ADDED AS THE
HYDROCHLORIDE SALT) 464 mg
PHENYLALANINE 448 mg
HISTIDINE 384 mg
THREONINE 336 mg
METHIONINE 320 mg
TRYPTOPHAN 144 mg
NONESSENTIAL AMINO ACIDS
ALANINE 1656 mg
ARGININE 920 mg
GLYCINE 824 mg
PROLINE 544 mg
SERINE 400 mg
TYROSINE 32 mg
ELECTROLYTES
DIBASIC POTASSIUM
PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 205 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE
DIHYDRATE USP 33 mg
mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 83
CHLORIDE 76
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS

pH ADJUSTED WITH GLACIAL ACETIC ACID AND HYDROCHLORIC ACID

STERILE

SINGLE DOSE CONTAINER

STORE AT ROOM TEMPERATURE (25ºC/77ºF)
IN UNOPENED OVERWRAP

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGo
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

LOT

BE-35-04-044

EADB9965

2000 mL

NDC 0338-0206-01

CLINIMIX E
WITH ELECTROLYTES 8/14

SULFITE-FREE
(8% Amino Acids
with Electrolytes in
14% Dextrose with
Calcium) Injection

CENTRAL LINE INFUSION ONLY

720 mL INJECTION PORT CHAMBER

39% Dextrose Injection with Calcium

1280 mL OUTLET PORT CHAMBER

12.5% Amino Acid Injection
with Electrolytes

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND
EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

EADB9965

Exp

CONTENTS OF EACH 100 mL OF THE
ADMIXED INJECTION
DEXTROSE HYDROUS USP 14 g

ESSENTIAL AMINO ACIDS
LEUCINE 584 mg
ISOLEUCINE 480 mg
VALINE 464 mg
LYSINE (ADDED AS THE
HYDROCHLORIDE SALT) 464 mg
PHENYLALANINE 448 mg
HISTIDINE 384 mg
THREONINE 336 mg
METHIONINE 320 mg
TRYPTOPHAN 144 mg

NONESSENTIAL AMINO ACIDS
ALANINE 1656 mg
ARGININE 920 mg
GLYCINE 824 mg
PROLINE 544 mg
SERINE 400 mg
TYROSINE 32 mg

ELECTROLYTES
DIBASIC POTASSIUM
PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 205 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE
DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 83
CHLORIDE 76
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS

pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE

SINGLE DOSE CONTAINER

STORE AT ROOM TEMPERATURE (25ºC/77ºF)
IN UNOPENED OVERWRAP

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

Lot

BE-35-04-048

EADB9943

1000 mL

NDC 0338-0210-01

CLINIMIX E
WITH ELECTROLYTES 8/10

SULFITE-FREE
(8% Amino Acids
with Electrolytes in
10% Dextrose with
Calcium) Injection

CENTRAL LINE INFUSION ONLY

360 mL INJECTION PORT CHAMBER
28% Dextrose Injection with Calcium

640 mL OUTLET PORT CHAMBER
12.5% Amino Acid Injection with Electrolytes

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

EXP

CONTENTS OF EACH 100 mL
OF THE ADMIXED INJECTION
DEXTROSE HYDROUS USP 10 g

NONESSENTIAL AMINO ACIDS
ALANINE 1656 mg
ARGININE 920 mg
GLYCINE 824 mg
PROLINE 544 mg
SERINE 400 mg
TYROSINE 32 mg

ELECTROLYTES
DIBASIC POTASSIUM
PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 205 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE
DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 83
CHLORIDE 76
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID
STERILE
SINGLE DOSE CONTAINER
STORE AT ROOM TEMPERATURE (25ºC/77ºF)
IN UNOPENED OVERWRAP
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

LOT

BE-35-04-042

EADB9945

2000 mL

NDC 0338-0214-01

CLINIMIX E
WITH ELECTROLYTES 8/10

SULFITE-FREE
(8% Amino Acids
with Electrolytes in
10% Dextrose with
Calcium) Injection

CENTRAL LINE INFUSION ONLY

720 mL INJECTION PORT CHAMBER

28% Dextrose Injection with Calcium

1280 mL OUTLET PORT CHAMBER

12.5% Amino Acid Injection
with Electrolytes

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESCRIBING INFORMATION FOR INSTRUCTIONS ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO 9 DAYS
ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT ALTER THE QUALITY AND
EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

Exp

CONTENTS OF EACH 100 mL OF THE
ADMIXED INJECTION
DEXTROSE HYDROUS USP 10 g

NONESSENTIAL AMINO ACIDS
ALANINE 1656 mg
ARGININE 920 mg
GLYCINE 824 mg
PROLINE 544 mg
SERINE 400 mg
TYROSINE 32 mg

ELECTROLYTES
DIBASIC POTASSIUM
PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 205 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE
DIHYDRATE USP 33 mg

mEq/L
SODIUM35
POTASSIUM30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 83
CHLORIDE 76
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS

pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE

SINGLE DOSE CONTAINER

STORE AT ROOM TEMPERATURE (25ºC/77ºF)
IN UNOPENED OVERWRAP

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

Lot

BE35-04-046

Container Label

2B7735L
NDC 0338-7020-01
1000 mL

Barcode
(01) 00303387020013

CLINIMIX E
WITH ELECTROLYTES 2.75/5
SULFITE-FREE

(2.75% Amino Acids with Electrolytes in
5% Dextrose with Calcium) Injection

500 mL INJECTION PORT CHAMBER
10% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
5.5% Amino Acid Injection

Rx Only

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR
INSTRUCTIONS ON ACTIVATION

AFTER MIXING THE PRODUCT
REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO
9 DAYS ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT
ALTER THE QUALITY AND EFFICACY OF
THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE
COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION
DEXTROSE HYDROUS USP 5 g
ESSENTIAL AMINO ACIDS
LEUCINE 201 mg
ISOLEUCINE 165 mg
VALINE 160 mg
LYSINE (ADDED AS THE
HYDROCHLORIDE SALT) 159 mg
PHENYLALANINE 154 mg
HISTIDINE 132 mg
THREONINE 116 mg
METHIONINE 110 mg
TRYPTOPHAN 50 mg
NONESSENTIAL AMINO ACIDS
ALANINE 570 mg
ARGININE 316 mg
GLYCINE 283 mg
PROLINE 187 mg
SERINE 138 mg
TYROSINE 11 mg
ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 216 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 112 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg
mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 51
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)
BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
STERILE SINGLE DOSE CONTAINER
STORE AT ROOM TEMPERATURE (25°C/77°F)
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

1600

1000

800

600

400

BE-35-05-069

200

Container Label

2B7737L
NDC 0338-7022-03
1000 mL

Barcode
(01) 00303387022017

CLINIMIX E
WITH ELECTROLYTES 4.25/5
SULFITE-FREE
(4.25% Amino Acids with Electrolytes in
5% Dextrose with Calcium) Injection

500 mL INJECTION PORT CHAMBER
10% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
8.5% Amino Acid Injection with Electrolytes

Rx Only

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR
INSTRUCTIONS ON ACTIVATION

AFTER MIXING THE PRODUCT
REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED
TO 9 DAYS ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT
ALTER THE QUALITY AND EFFICACY OF
THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE
COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION
DEXTROSE HYDROUS USP 5 g
ESSENTIAL AMINO ACIDS
LEUCINE 311 mg
ISOLEUCINE 255 mg
VALINE 247 mg
LYSINE (ADDED AS THE
HYDROCHLORIDE SALT) 247 mg
PHENYLALANINE 238 mg
HISTIDINE 204 mg
THREONINE 179 mg
METHIONINE 170 mg
TRYPTOPHAN 77 mg
NONESSENTIAL AMINO ACIDS
ALANINE 880 mg
ARGININE 489 mg
GLYCINE 438 mg
PROLINE 289 mg
SERINE 213 mg
TYROSINE 17 mg
ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 297 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 77 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg
mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 70
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)
BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID
STERILE SINGLE DOSE CONTAINER
STORE AT ROOM TEMPERATURE (25°C/77°F)
IN UNOPENED OVERWRAP
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

1600

1000

800

600

400

BE-35-05-069

200

Container Label

2B7716L
NDC 0338-7024-01
2000 mL

Barcode
(01) 00303387024011

CLINIMIX E
WITH ELECTROLYTES 4.25/5

SULFITE-FREE

(4.25% Amino Acids
with Electrolytes in
5% Dextrose with
Calcium) Injection

1000 mL INJECTION PORT CHAMBER
10% Dextrose Injection with Calcium

1000 mL OUTLET PORT CHAMBER
8.5% Amino Acid Injection with
Electrolytes

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO
9 DAYS ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION
DEXTROSE HYDROUS USP 5 g

ESSENTIAL AMINO ACIDS
LEUCINE 311 mg
ISOLEUCINE 255 mg
VALINE 247 mg
LYSINE (ADDED AS
THE HYDROCHLORIDE SALT) 247 mg
PHENYLALANINE 238 mg
HISTIDINE 204 mg
THREONINE 179 mg
METHIONINE 170 mg
TRYPTOPHAN 77 mg

NONESSENTIAL AMINO ACIDS
ALANINE 880 mg
ARGININE 489 mg
GLYCINE 438 mg
PROLINE 289 mg
SERINE 213 mg
TYROSINE 17 mg

ELECTROLYTES
SODIUM ACETATE
TRIHYDRATE USP 297 mg
DIBASIC POTASSIUM
PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 77 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE
DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 70
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE
SINGLE DOSE CONTAINER

STORE AT ROOM TEMPERATURE (25°C/77°F)
IN UNOPENED OVERWRAP

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

2000

1600

1000

800

600

400

BE-35-05-064

200

Container Label

2B7738L
NDC 0338-7026-01
1000 mL

Barcode
(01) 00303387026015

CLINIMIX E
WITH ELECTROLYTES 4.25/10

SULFITE-FREE

(4.25% Amino Acids with Electrolytes in
10% Dextrose with Calcium) Injection

CENTRAL LINE INFUSION ONLY

500 mL INJECTION PORT CHAMBER
20% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
8.5% Amino Acid Injection with Electrolytes

Rx Only

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR
INSTRUCTIONS ON ACTIVATION

AFTER MIXING THE PRODUCT
REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO
9 DAYS ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT
ALTER THE QUALITY AND EFFICACY
OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE
COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION
DEXTROSE HYDROUS USP 10 g

ESSENTIAL AMINO ACIDS
LEUCINE 311 mg
ISOLEUCINE 255 mg
VALINE 247 mg
LYSINE (ADDED AS THE
HYDROCHLORIDE SALT) 247 mg
PHENYLALANINE 238 mg
HISTIDINE 204 mg
THREONINE 179 mg
METHIONINE 170 mg
TRYPTOPHAN 77 mg

NONESSENTIAL AMINO ACIDS
ALANINE 880 mg
ARGININE 489 mg
GLYCINE 438 mg
PROLINE 289 mg
SERINE 213 mg
TYROSINE 17 mg

ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 297 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 77 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 70
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)
BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE SINGLE DOSE CONTAINER

STORE AT ROOM TEMPERATURE (25°C/77°F)
IN UNOPENED OVERWRAP
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

1600

1000

800

600

400

BE-35-05-070

200

Container Label

2B7717L
NDC 0338-7026-01
2000 mL

Barcode
(01) 00303387028019

CLINIMIX E
WITH ELECTROLYTES 4.25/5

SULFITE-FREE

(4.25% Amino Acids
with Electrolytes in
5% Dextrose with
Calcium) Injection

CENTRL LINE INFUSION ONLY

1000 mL INJECTION PORT CHAMBER
10% Dextrose Injection with Calcium

1000 mL OUTLET PORT CHAMBER
8.5% Amino Acid Injection
with Electrolytes

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO
9 DAYS ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION
DEXTROSE HYDROUS USP 5 g

NONESSENTIAL AMINO ACIDS
ALANINE 880 mg
ARGININE 489 mg
GLYCINE 438 mg
PROLINE 289 mg
SERINE 213 mg
TYROSINE 17 mg

ELECTROLYTES
SODIUM ACETATE
TRIHYDRATE USP 297 mg
DIBASIC POTASSIUM
PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 77 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE
DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 70
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE
SINGLE DOSE CONTAINER

STORE AT ROOM TEMPERATURE (25°C/77°F)
IN UNOPENED OVERWRAP

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

2000

1600

1000

800

600

400

BE-35-05-065

200

Container Label

2B7740L
NDC 0338-7030-01
1000 mL

Bacode
(01) 00303387030012

CLINIMIX E
WITH ELECTROLYTES 5/15

SULFITE-FREE
(5% Amino Acid with Electrolytes in
15% Dextrose with Calcium) Injection

CENTRAL LINE INFUSION ONLY

500 mL INJECTION PORT CHAMBER
30% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
10% Amino Acid Injection

Rx Only

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR
INSTRUCTIONS ON ACTIVATION

AFTER MIXING THE PRODUCT
REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO
9 DAYS ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT
ALTER THE QUALITY AND EFFICACY OF
THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE
COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION
DEXTROSE HYDROUS USP 15 g

ESSENTIAL AMINO ACIDS
LEUCINE 365 mg
ISOLEUCINE 300 mg
VALINE 290 mg
LYSINE (ADDED AS THE
HYDROCHLORIDE SALT) 290 mg
PHENYLALANINE 280 mg
HISTIDINE 240 mg
THREONINE 210 mg
METHIONINE 200 mg
TRYPTOPHAN 90 mg

NONESSENTIAL AMINO ACIDS
ALANINE 1035 mg
ARGININE 575 mg
GLYCINE 515 mg
PROLINE 340 mg
SERINE 250 mg
TYROSINE 20 mg

ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 340 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 59 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 80
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE SINGLE DOSE CONTAINER

ROOM TEMPERATURE (25°C/77°F)
IN UNOPENED OVERWRAP
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

1600

1000

800

600

400

BE-35-05-071

200

Container Label

2B7721L
NDC 0338-7032-01
2000 mL

Barcode
(01) 00303387032016

CLINIMIX E
WITH ELECTROLYTES 5/15

SULFITE-FREE

(5% Amino Acids
with Electrolytes in
15% Dextrose with
Calcium) Injection

CENTRAL LINE INFUSION ONLY

1000 mL INJECTION PORT CHAMBER
30% Dextrose Injection with Calcium

1000 mL OUTLET PORT CHAMBER
10% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO
9 DAYS ONCE OVERWARP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION
DEXTROSE HYDROUS USP 15

NONESSENTIAL AMINO ACIDS
ALANINE 1035 mg
ARGININE 575 mg
GLYCINE 515 mg
PROLINE 340 mg
SERINE 250 mg
TYROSINE 20 mg

ELECTROLYTES
SODIUM ACETATE
TRIHYDRATE USP 340 mg
DIBASIC POTASSIUM
PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 59 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 80
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE
SINGLE DOSE CONTAINER

ROOM TEMPERATURE (25°C/77°F)
IN UNOPENED OVERWRAP

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

2000

1600

1000

800

600

400

BE-35-05-066

200

Container Label

2B7741L
NDC 0338-7034-01
1000 mL

Barcode
(01) 00303387034010

CLINIMIX E
WITH ELECTROLYTES 5/20

SULFITE-FREE

(5% Amino Acids with Electrolytes in
20% Dextrose with Calcium) Injection

CENTRAL LINE INFUSION ONLY

500 mL INJECTION PORT CHAMBER
40% Dextrose Injection with Calcium

500 mL OUTLET PORT CHAMBER
10% Amino Acid Injection

Rx Only

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR
INSTRUCTIONS ON ACTIVATION

AFTER MIXING THE PRODUCT
REPRESENTS 1000 mL

REFRIGERATED STORAGE IS LIMITED TO
9 DAYS ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT
ALTER THE QUALITY AND EFFICACY OF
THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE
COMPATIBILITY

CONTENTS OF EACH 100 mL OF THE ADMIXED INJECTION
DEXTROSE HYDROUS USP 20 g

NONESSENTIAL AMINO ACIDS
ALANINE 1035 mg
ARGININE 575 mg
GLYCINE 515 mg
PROLINE 340 mg
SERINE 250 mg
TYROSINE 20 mg

ELECTROLYTES
SODIUM ACETATE TRIHYDRATE USP 340 mg
DIBASIC POTASSIUM PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 59 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 80
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE SINGLE DOSE CONTAINER

ROOM TEMPERATURE (25°C/77°F)
IN UNOPENED OVERWRAP
AVOID EXCESSIVE HEAT
PROTECT FROM FREEZING
SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

1600

1000

800

600

400

BE-35-05-072

200

Container Label

2B7722L
NDC 0338-7036-01
2000 mL

Barcode
(01) 00303387032016

CLINIMIX E
WITH ELECTROLYTES 5/20

SULFITE-FREE

(5% Amino Acids
with Electrolytes in
20% Dextrose with
Calcium) Injection

CENTRAL LINE INFUSION ONLY

1000 mL INJECTION PORT CHAMBER
40% Dextrose Injection with Calcium

1000 mL OUTLET PORT CHAMBER
10% Amino Acid Injection

Rx Only

ACTIVATE SEAL AND
MIX THOROUGHLY BEFORE USE

SEE PRESRCIBING INFORMATION FOR INSTRUCTIONS
ON ACTIVATION

AFTER MIXING THE PRODUCT REPRESENTS 2000 mL

REFRIGERATED STORAGE IS LIMITED TO
9 DAYS ONCE OVERWRAP IS OPENED

A SLIGHT YELLOW COLOR DOES NOT ALTER THE
QUALITY AND EFFICACY OF THIS PRODUCT

ASK PHARMACIST ABOUT ADDITIVE COMPATIBILITY

2D Datamatrix (GS1):
NDC, LOT, EXP

2D Datamatrix
Barcode

CONTENTS OF EACH 100 mL OF THE ADMIXED
INJECTION
DEXTROSE HYDROUS USP 20 g

NONESSENTIAL AMINO ACIDS
ALANINE 1035 mg
ARGININE 575 mg
GLYCINE 515 mg
PROLINE 340 mg
SERINE 250 mg
TYROSINE 20 mg

ELECTROLYTES
SODIUM ACETATE
TRIHYDRATE USP 340 mg
DIBASIC POTASSIUM
PHOSPHATE USP 261 mg
SODIUM CHLORIDE USP 59 mg
MAGNESIUM CHLORIDE USP 51 mg
CALCIUM CHLORIDE
DIHYDRATE USP 33 mg

mEq/L
SODIUM 35
POTASSIUM 30
MAGNESIUM 5
CALCIUM 4.5 (2.2 mmol/L)
ACETATE 80
CHLORIDE 39
PHOSPHATE 30 (15 mmol/L)

BALANCED BY IONS FROM AMINO ACIDS
pH ADJUSTED WITH GLACIAL ACETIC ACID
AND HYDROCHLORIC ACID

STERILE
SINGLE DOSE CONTAINER

ROOM TEMPERATURE (25°C/77°F)
IN UNOPENED OVERWARP

AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING

SEE PRESCRIBING INFORMATION

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA
MADE IN BELGIUM

EXP LOT

2000

1600

1000

800

600

400

BE-35-05-066

200

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1090639	CLINIMIX E 4.25/10 (Injectable)	alanine 8.8 MG/ML / arginine 4.89 MG/ML / calcium chloride 0.004 MEQ/ML / dibasic potassium phosphate 2.61 MG/ML / glucose 100 MG/ML / glycine 4.38 MG/ML / histidine 2.04 MG/ML / isoleucine 2.55 MG/ML / leucine 3.11 MG/ML / lysine 2.47 MG/ML / magnesium chloride 0.01 MEQ/ML / methionine 1.7 MG/ML / phenylalanine 2.38 MG/ML / proline 2.89 MG/ML / serine 2.13 MG/ML / sodium acetate trihydrate 2.97 MG/ML / sodium chloride 0.013 MEQ/ML / threonine 1.79 MG/ML / tryptophan 0.77 MG/ML / tyrosine 0.17 MG/ML / valine 2.47 MG/ML Injectable Solution [Clinimix E 4.25/10]	SBD Active

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Code 128	(01)00303387020013	GTIN-14: 00303387020013 GTIN-12: 303387020013 UPC-A: 303387020013 EAN-13: 0303387020013 GTIN storage (14 digits): 00303387020013	image-17.jpg
Barcode	Code 128	(01)00303387022017	GTIN-14: 00303387022017 GTIN-12: 303387022017 UPC-A: 303387022017 EAN-13: 0303387022017 GTIN storage (14 digits): 00303387022017	image-18.jpg
Barcode	Code 128	(01)00303387024011	GTIN-14: 00303387024011 GTIN-12: 303387024011 UPC-A: 303387024011 EAN-13: 0303387024011 GTIN storage (14 digits): 00303387024011	image-19.jpg
Barcode	Code 128	(01)00303387026015	GTIN-14: 00303387026015 GTIN-12: 303387026015 UPC-A: 303387026015 EAN-13: 0303387026015 GTIN storage (14 digits): 00303387026015	image-20.jpg
Barcode	Code 128	(01)00303387028019	GTIN-14: 00303387028019 GTIN-12: 303387028019 UPC-A: 303387028019 EAN-13: 0303387028019 GTIN storage (14 digits): 00303387028019	image-21.jpg
Barcode	Code 128	(01)00303387030012	GTIN-14: 00303387030012 GTIN-12: 303387030012 UPC-A: 303387030012 EAN-13: 0303387030012 GTIN storage (14 digits): 00303387030012	image-22.jpg
Barcode	Code 128	(01)00303387032016	GTIN-14: 00303387032016 GTIN-12: 303387032016 UPC-A: 303387032016 EAN-13: 0303387032016 GTIN storage (14 digits): 00303387032016	image-23.jpg, image-25.jpg
Barcode	Code 128	(01)00303387034010	GTIN-14: 00303387034010 GTIN-12: 303387034010 UPC-A: 303387034010 EAN-13: 0303387034010 GTIN storage (14 digits): 00303387034010	image-24.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767	Product name	4	20250516
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
334fe8d2-68fb-4331-a576-420e302ec069	Product name	7	20240320
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e92765c1-be81-432a-b909-1b10777ec378	Product name	1	20190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0441a8f5-3835-497c-aedd-bc78cba56b2a	Product name	1	20150317
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0338-1113-04	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1113-04	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1115-04	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1115-04	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1123-04	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1123-04	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1125-04	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1125-04	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1142-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1142-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1144-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1144-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1145-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1145-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1147-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1147-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1148-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1148-03	2020-10-02	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1113-04	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1113-04	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1115-04	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1115-04	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1123-04	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1123-04	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1125-04	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1125-04	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1142-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1142-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1144-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1144-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1145-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1145-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1147-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1147-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1148-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1148-03	2020-09-27	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1113-04	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1113-04	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1115-04	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1115-04	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1123-04	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1123-04	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1125-04	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1125-04	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1142-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1142-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1144-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1144-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1145-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1145-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1147-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1147-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1148-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1148-03	2020-09-25	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1113-04	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1113-04	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1115-04	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1115-04	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1123-04	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1123-04	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1125-04	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1125-04	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1142-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1142-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1144-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1144-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1145-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1145-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1147-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1147-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1148-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997
0338-1148-03	2020-07-22	C162847	48780-1	ab0e2407-264e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use CLINIMIX E safely and effectively. See full prescribing information for CLINIMIX E. CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection, for intravenous use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1142-03	ML - Milliliter	0338-1142	5cfd1ee5-c153-4041-8f83-e083084094a8	1	2012-07-24
0338-1144-03	ML - Milliliter	0338-1144	3888ed5e-dd19-469e-8b55-065de77acebd	1	2012-07-24
0338-1113-04	ML - Milliliter	0338-1113	36dee342-da54-4f53-97af-ae309cb843af	1	2012-07-24
0338-1145-03	ML - Milliliter	0338-1145	b6c77a1a-8a56-446b-b67b-217603640fd3	1	2012-07-24
0338-1115-04	ML - Milliliter	0338-1115	b58e42dd-51cc-4ada-97b5-da2d9f4a906c	1	2012-07-24
0338-1147-03	ML - Milliliter	0338-1147	c16e698c-97c7-4745-9fd4-99a62fa43953	1	2012-07-24
0338-1123-04	ML - Milliliter	0338-1123	a832f5cd-3b45-456b-bd3d-9c6bc9a349ca	1	2012-07-24
0338-1125-04	ML - Milliliter	0338-1125	cf29b963-5ff9-4552-8520-8a4ab8d14b77	1	2012-07-24
0338-1148-03	ML - Milliliter	0338-1148	34602062-3db3-40a3-b3e8-4ba6d963259c	1	2012-07-24
0338-7020-01	ML - Milliliter	0338-7020	4bedcde0-03c7-44cc-8bbb-c3037003deb1	1	2024-10-04
0338-7020-06	ML - Milliliter	0338-7020	b3212963-5409-4266-abc5-75b50aa999dd	1	2024-10-04
0338-7022-01	ML - Milliliter	0338-7022	3e727b23-575a-4956-a5c3-0c0b6b62336b	1	2024-10-04
0338-7022-06	ML - Milliliter	0338-7022	e4933285-017e-40d1-baca-d5c24fbdbb32	1	2024-10-04
0338-7024-01	ML - Milliliter	0338-7024	0918dfb4-f0e7-4369-a9fe-9da1e05542fc	1	2024-10-04
0338-7024-04	ML - Milliliter	0338-7024	aeceb00e-1869-4eea-a677-b752b4022397	1	2024-10-04
0338-7026-01	ML - Milliliter	0338-7026	2ececc44-6c7b-4b24-8c59-d2c31c5d4061	1	2024-10-04
0338-7026-06	ML - Milliliter	0338-7026	a15bdb12-5fa5-45de-81bd-b380a00be593	1	2024-10-04
0338-7028-01	ML - Milliliter	0338-7028	968a1722-68eb-47b1-b26d-5182a915f628	1	2024-10-04
0338-7028-04	ML - Milliliter	0338-7028	9bc063a9-6e3b-4165-9743-0ca5c184c19c	1	2024-10-04
0338-7030-01	ML - Milliliter	0338-7030	11f8f2c5-5549-4778-a1e7-5e9502741558	1	2024-10-04
0338-7030-06	ML - Milliliter	0338-7030	314f3395-f60d-4b87-9e12-14a034a00302	1	2024-10-04
0338-7032-01	ML - Milliliter	0338-7032	3fcf64ab-7aa4-47a7-a03c-392503379549	1	2024-10-04
0338-7032-04	ML - Milliliter	0338-7032	54374053-da7e-42de-bbd3-6f6e79ebbe09	1	2024-10-04
0338-7034-01	ML - Milliliter	0338-7034	35f48a38-6ef9-4f02-a1da-4a342c14a47a	1	2024-10-04
0338-7034-06	ML - Milliliter	0338-7034	1117ceee-f0ef-4f6f-9e28-d0acc5459d87	1	2024-10-04
0338-7036-01	ML - Milliliter	0338-7036	4c091e6c-b4e1-4e1f-94ec-6f540e29d30b	1	2024-10-04
0338-7036-04	ML - Milliliter	0338-7036	ef2bebb1-5ead-4d01-9f9e-88238c71dcde	1	2024-10-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Alanine	ACTIVE INGREDIENT	OF5P57N2ZX	1
ARGININE	ACTIVE INGREDIENT	94ZLA3W45F	1
CALCIUM CHLORIDE	ACTIVE INGREDIENT	M4I0D6VV5M	1
DEXTROSE	ACTIVE INGREDIENT	IY9XDZ35W2	1
Glycine	ACTIVE INGREDIENT	TE7660XO1C	1
HISTIDINE	ACTIVE INGREDIENT	4QD397987E	1
ISOLEUCINE	ACTIVE INGREDIENT	04Y7590D77	1
LEUCINE	ACTIVE INGREDIENT	GMW67QNF9C	1
LYSINE	ACTIVE INGREDIENT	K3Z4F929H6	1
MAGNESIUM CHLORIDE	ACTIVE INGREDIENT	02F3473H9O	1
METHIONINE	ACTIVE INGREDIENT	AE28F7PNPL	1
PHENYLALANINE	ACTIVE INGREDIENT	47E5O17Y3R	1
POTASSIUM PHOSPHATE, DIBASIC	ACTIVE INGREDIENT	CI71S98N1Z	1
PROLINE	ACTIVE INGREDIENT	9DLQ4CIU6V	1
PROLINE, DL-	ACTIVE INGREDIENT	DCS9E77JPQ	1
SERINE	ACTIVE INGREDIENT	452VLY9402	1
SODIUM ACETATE	ACTIVE INGREDIENT	4550K0SC9B	1
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	1
THREONINE	ACTIVE INGREDIENT	2ZD004190S	1
TRYPTOPHAN	ACTIVE INGREDIENT	8DUH1N11BX	1
TYROSINE	ACTIVE INGREDIENT	42HK56048U	1
VALINE	ACTIVE INGREDIENT	HG18B9YRS7	1
Alanine	ACTIVE MOIETY	OF5P57N2ZX	1
ALANINE, DL-	ACTIVE MOIETY	1FU7983T0U	1
ARGININE	ACTIVE MOIETY	94ZLA3W45F	1
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	1
DEXTROSE	ACTIVE MOIETY	IY9XDZ35W2	1
Glycine	ACTIVE MOIETY	TE7660XO1C	1
HISTIDINE	ACTIVE MOIETY	4QD397987E	1
ISOLEUCINE	ACTIVE MOIETY	04Y7590D77	1
LEUCINE	ACTIVE MOIETY	GMW67QNF9C	1
LYSINE	ACTIVE MOIETY	K3Z4F929H6	1
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	1
METHIONINE	ACTIVE MOIETY	AE28F7PNPL	1
PHENYLALANINE	ACTIVE MOIETY	47E5O17Y3R	1
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	1
PROLINE	ACTIVE MOIETY	9DLQ4CIU6V	1
SERINE	ACTIVE MOIETY	452VLY9402	1
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	1
THREONINE	ACTIVE MOIETY	2ZD004190S	1
TRYPTOPHAN	ACTIVE MOIETY	8DUH1N11BX	1
TYROSINE	ACTIVE MOIETY	42HK56048U	1
VALINE	ACTIVE MOIETY	HG18B9YRS7	1
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	1
NITROGEN	INACTIVE INGREDIENT	N762921K75	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

CLINIMIX E
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose
LEUCINE
PHENYLALANINE
LYSINE
METHIONINE
ISOLEUCINE
VALINE
HISTIDINE
THREONINE
TRYPTOPHAN
ALANINE
GLYCINE
ARGININE
PROLINE
SERINE
TYROSINE
SODIUM ACETATE
ACETATE ION
SODIUM CATION
POTASSIUM PHOSPHATE, DIBASIC
PHOSPHATE ION
POTASSIUM CATION
MAGNESIUM CHLORIDE
MAGNESIUM CATION
CHLORIDE ION
SODIUM CHLORIDE
CALCIUM CHLORIDE
CALCIUM CATION
DEXTROSE
ANHYDROUS DEXTROSE
ACETIC ACID
WATER
NITROGEN
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose
HYDROCHLORIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0338-1142	0338-1142-03
0338-1144	0338-1144-03
0338-1113	0338-1113-04
0338-1145	0338-1145-03
0338-1115	0338-1115-04
0338-1147	0338-1147-03
0338-1123	0338-1123-04
0338-1125	0338-1125-04
0338-1148	0338-1148-03
0338-0202	0338-0202-01, 0338-0202-06
0338-0206	0338-0206-01, 0338-0206-04
0338-0210	0338-0210-01, 0338-0210-06
0338-0214	0338-0214-01, 0338-0214-04
0338-7020	0338-7020-01, 0338-7020-06
0338-7022	0338-7022-01, 0338-7022-06
0338-7024	0338-7024-01, 0338-7024-04
0338-7026	0338-7026-01, 0338-7026-06
0338-7028	0338-7028-01, 0338-7028-04
0338-7030	0338-7030-01, 0338-7030-06
0338-7032	0338-7032-01, 0338-7032-04
0338-7034	0338-7034-01, 0338-7034-06
0338-7036	0338-7036-01, 0338-7036-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 14 · 537 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LEUCINE	GMW67QNF9C	ACTIB
PHENYLALANINE	47E5O17Y3R	ACTIB
LYSINE	K3Z4F929H6	ACTIB
METHIONINE	AE28F7PNPL	ACTIB
ISOLEUCINE	04Y7590D77	ACTIB
VALINE	HG18B9YRS7	ACTIB
HISTIDINE	4QD397987E	ACTIB
THREONINE	2ZD004190S	ACTIB
TRYPTOPHAN	8DUH1N11BX	ACTIB
ALANINE	OF5P57N2ZX	ACTIB
GLYCINE	TE7660XO1C	ACTIB
ARGININE	94ZLA3W45F	ACTIB
PROLINE	9DLQ4CIU6V	ACTIB
SERINE	452VLY9402	ACTIB
TYROSINE	42HK56048U	ACTIB
SODIUM ACETATE	4550K0SC9B	ACTIB
POTASSIUM PHOSPHATE, DIBASIC	CI71S98N1Z	ACTIB
MAGNESIUM CHLORIDE	02F3473H9O	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
CALCIUM CHLORIDE	M4I0D6VV5M	ACTIB
DEXTROSE	IY9XDZ35W2	ACTIB
ACETIC ACID	Q40Q9N063P	IACT
WATER	059QF0KO0R	IACT
NITROGEN	N762921K75	IACT
LEUCINE	GMW67QNF9C	ACTIB
PHENYLALANINE	47E5O17Y3R	ACTIB
LYSINE	K3Z4F929H6	ACTIB
METHIONINE	AE28F7PNPL	ACTIB
ISOLEUCINE	04Y7590D77	ACTIB
VALINE	HG18B9YRS7	ACTIB
HISTIDINE	4QD397987E	ACTIB
THREONINE	2ZD004190S	ACTIB
TRYPTOPHAN	8DUH1N11BX	ACTIB
ALANINE	OF5P57N2ZX	ACTIB
GLYCINE	TE7660XO1C	ACTIB
ARGININE	94ZLA3W45F	ACTIB
PROLINE	9DLQ4CIU6V	ACTIB
SERINE	452VLY9402	ACTIB
TYROSINE	42HK56048U	ACTIB
SODIUM ACETATE	4550K0SC9B	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
16	2021-04-13	full-release	2026-05-31 21:32:56

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 57 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates
ACETIC ACID	ACETIC ACID	Q40Q9N063P	INJECTION / INTRAVENOUS	827 mg	Exact identifier — unii+route+dosage form 57 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020678-001	CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-002	CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-005	CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-008	CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-009	CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-011	CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-012	CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-016	CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-017	CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-018	CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-019	CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26
N020678-021	CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER	AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE	5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 14 · 528 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020678-001	CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-002	CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-005	CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-008	CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-009	CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-011	CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-012	CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-016	CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-017	CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-018	CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-019	CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020678-021	CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020678-001	CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-002	CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-005	CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-008	CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-009	CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-011	CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-012	CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-016	CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-017	CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-018	CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-019	CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020678-021	CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020678-001	CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-002	CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-005	CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-008	CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-009	CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-011	CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-012	CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-016	CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-017	CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;15GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-018	CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;20GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-019	CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020678-021	CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER	5%;33MG/100ML;35GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020678-001	CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020678-002	CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020678-005	CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	2.75%;33MG/100ML;25GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020678-008	CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER	4.25%;33MG/100ML;5GM/100ML;51MG/100ML;261MG/100ML;297MG/100ML;77MG/100ML	INJECTABLE / INJECTION	RLD, RS	1997-03-26	`011fe1cb6892…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier ndc (package): 0338-0202-01 ndc (package): 0338-7034-06 ndc (package): 0338-0214-01 ndc (package): 0338-7026-01 ndc (package): 0338-1145-03 ndc (package): 0338-7032-01 ndc (package): 0338-1142-03 ndc (package): 0338-1148-03 ndc (package): 0338-1123-04 ndc (package): 0338-1125-04 ndc (package): 0338-1115-04 ndc (package): 0338-7028-04 ndc (package): 0338-7022-06 ndc (package): 0338-7020-06 ndc (package): 0338-7030-06 ndc (package): 0338-7028-01 ndc (package): 0338-1113-04 ndc (package): 0338-0214-04 ndc (package): 0338-1144-03 ndc (package): 0338-7024-04 ndc (package): 0338-7024-01 ndc (package): 0338-7034-01 ndc (package): 0338-0202-06 ndc (package): 0338-7022-01 ndc (package): 0338-7036-01 ndc (package): 0338-7036-04 ndc (package): 0338-0210-06 ndc (package): 0338-7030-01 ndc (package): 0338-0206-04 ndc (package): 0338-1147-03 ndc (package): 0338-7032-04 ndc (package): 0338-7026-06 ndc (package): 0338-0206-01 ndc (package): 0338-7020-01 ndc (package): 0338-0210-01 ndc (product): 0338-1142 ndc (product): 0338-1115 ndc (product): 0338-0210 ndc (product): 0338-7026 ndc (product): 0338-7022 ndc (product): 0338-1144 ndc (product): 0338-7028 ndc (product): 0338-0214 ndc (product): 0338-1145 ndc (product): 0338-7036 ndc (product): 0338-0202 ndc (product): 0338-1148 ndc (product): 0338-7032 ndc (product): 0338-1147 ndc (product): 0338-7030 ndc (product): 0338-1125 ndc (product): 0338-7034 ndc (product): 0338-7020 ndc (product): 0338-1123 ndc (product): 0338-7024 ndc (product): 0338-0206 ndc (product): 0338-1113 ndc11 (package): 00338111304 ndc11 (package): 00338703204 ndc11 (package): 00338112504 ndc11 (package): 00338702804 ndc11 (package): 00338114403 ndc11 (package): 00338020604 ndc11 (package): 00338703201 ndc11 (package): 00338114503 ndc11 (package): 00338702606 ndc11 (package): 00338114803 ndc11 (package): 00338114703 ndc11 (package): 00338702206 ndc11 (package): 00338703006 ndc11 (package): 00338111504 ndc11 (package): 00338703601 ndc11 (package): 00338703001 ndc11 (package): 00338021401 ndc11 (package): 00338703604 ndc11 (package): 00338703406 ndc11 (package): 00338702006 ndc11 (package): 00338702801 ndc11 (package): 00338021006 ndc11 (package): 00338021001 ndc11 (package): 00338020601 ndc11 (package): 00338702401 ndc11 (package): 00338702601 ndc11 (package): 00338112304 ndc11 (package): 00338702201 ndc11 (package): 00338020206 ndc11 (package): 00338114203 ndc11 (package): 00338020201 ndc11 (package): 00338021404 ndc11 (package): 00338702404 ndc11 (package): 00338702001 ndc11 (package): 00338703401 spl id: c5f1da6b-9b01-4814-97a5-3d7efbedec9c spl set id: 8469d6fb-d6ef-476f-8cc3-0905192de0a8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

CLINIMIX E

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Preparation Prior to Administration

2.2 Important Administration Instructions

2.3 Instructions for Use

2.4 Preparation and Addition of Lipid Emulsion

2.5 Dosing Considerations

2.6 Recommended Dosage in Adults

2.7 Dosage Modifications in Patients with Kidney Disease

2.8 Recommended Dosage in Pediatric Patients

2.9 Discontinuation of CLINIMIX E injection

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates

5.2 Precipitation with Ceftriaxone

5.3 Hypersensitivity Reactions

5.4 Risk of Infections

5.5 Refeeding Syndrome

5.6 Hyperglycemia or Hyperosmolar Hyperglycemic State

5.7 Vein Damage and Thrombosis

5.8 Hepatobiliary Disorders

5.9 Aluminum Toxicity

5.10 Risk of Parenteral Nutrition Associated Liver Disease

5.11 Electrolyte Imbalance and Fluid Overload

5.12 Monitoring/Laboratory Tests

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.1 Drugs that Can Cause Hyperkalemia

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Clinical Considerations

8.2 Lactation

Risk Summary

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

SPL UNCLASSIFIED SECTION

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

Product Linked Resources#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Older Hydrated Versions#

Inactive ingredient matches#

Orange Book application contexts#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#