Potassium Chloride in 0.9% Sodium Chloride Injection

Manufacturer
B. Braun Medical Inc.
Effective date
2025-07-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-05-31 21:59:24

Label at a glance#

ProductPOTASSIUM CHLORIDE IN SODIUM CHLORIDE
Active ingredientSODIUM CHLORIDE, POTASSIUM CHLORIDE
Label structure14 sections

Indications and uses

Potassium Chloride in 0.9% Sodium Chloride Injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.

Dosage and administration

This solution is for intravenous use. Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. When a hypertonic solution ...

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Each 100 mL of 20 mEq Potassium Chloride in 0.9% Sodium Chloride Injection (20 mEq K+/L) contains: Sodium Chloride USP 0.9 g
Potassium Chloride USP 0.15 g; Water for Injection USP qs

pH may be adjusted with Hydrochloric Acid NF

pH: 5.6 (3.5–6.5)              Calculated Osmolarity: 350 mOsmol/L

Concentration of Electrolytes (mEq/L):
Sodium 154             Potassium 20             Chloride 174

Potassium Chloride in 0.9% Sodium Chloride Injection is sterile, nonpyrogenic, hypertonic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration.

The formulas of the active ingredients are:

IngredientsMolecular
Formula
Molecular
Weight
 Sodium Chloride USP NaCl 58.44
 Potassium Chloride USP KCl 74.55

Not made with natural rubber latex, PVC or DEHP.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Potassium Chloride in 0.9% Sodium Chloride Injection provides electrolytes and is a source of water for hydration. It is capable of inducing diuresis depending on the clinical condition of the patient.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of acid-base equilibrium of body fluid.

Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Potassium Chloride in 0.9% Sodium Chloride Injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Potassium Chloride in 0.9% Sodium Chloride Injection is contraindicated in clinical conditions where additives of sodium, potassium or chloride could be clinically detrimental.

WARNINGS

WARNINGS SECTION

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there is sodium retention with edema.

Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient's circulatory system status as a guide.

In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

This solution should be used with care in patients with hypervolemia, renal insufficiency, urinary tract obstruction, or impending or frank cardiac decompensation.

Extraordinary electrolyte losses that may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

Additional essential electrolytes, minerals, and vitamins should be supplied as needed.

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Infusion of more than one liter of isotonic (0.9%) sodium chloride may supply more sodium and chloride than normally found in serum, and can exceed normal tolerance, resulting in hypernatremia; this may also cause a loss of bicarbonate ions, resulting in an acidifying effect.

Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels.

Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly when accompanied by renal disease.

Care should be exercised in administering solutions containing sodium or potassium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

Do not use plastic containers in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container.

This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container is undamaged.

Laboratory Tests

LABORATORY TESTS SECTION

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require tailoring of the electrolyte pattern, in this or alternative solutions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Studies with Potassium Chloride in 0.9% Sodium Chloride Injection have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy: Teratogenic Effects

PREGNANCY SECTION

Animal reproduction studies have not been conducted with Potassium Chloride in 0.9% Sodium Chloride Injection. It is also not known whether Potassium Chloride in 0.9% Sodium Chloride Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Chloride in 0.9% Sodium Chloride Injection should be given to a pregnant woman only if clearly needed.

Labor and Delivery

LABOR & DELIVERY SECTION

The effects of Potassium Chloride in 0.9% Sodium Chloride Injection on the duration of labor or delivery, on the possibility that forceps delivery or other intervention or resuscitation of the newborn will be necessary, and on the later growth, development, and functional maturation of the child are unknown. As reported in the literature, potassium containing solutions have been administered during labor and delivery. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

Nursing Mothers

NURSING MOTHERS SECTION

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Potassium Chloride in 0.9% Sodium Chloride Injection is administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness of Potassium Chloride in Sodium Chloride Injection in pediatric patients has not been established by adequate and well-controlled studies. However, as referenced in the medical literature, potassium chloride injection has been used to treat pediatric patients with potassium deficiency when oral replacement therapy is not feasible.

For patients receiving potassium supplement at greater than maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended.

In neonates or in very small infants even small volumes of fluid may affect fluid and electrolyte balance. Care must be exercised in treatment of neonates, especially preterm neonates, whose renal function may be immature and whose ability to excrete fluid and solute loads may be limited. Fluid intake, urine output, and serum electrolytes should be monitored closely.

See WARNINGS and DOSAGE AND ADMINISTRATION.

Geriatric Use

GERIATRIC USE SECTION

Clinical studies of Potassium Chloride in Sodium Chloride Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between 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 other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

See WARNINGS.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

Too rapid infusion of hypertonic solutions may cause local pain and venous irritation. Rate of administration should be adjusted according to tolerance. Use of the largest peripheral vein and a small bore needle is recommended.

(See DOSAGE AND ADMINISTRATION.)

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

Hypernatremia may be associated with edema and exacerbation of congestive heart failure due to the retention of water, resulting in an expanded extracellular fluid volume.

Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect.

The physician should also be alert to the possibility of adverse reactions to drug additives. Prescribing information for drug additives to be administered in this manner should be consulted.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

OVERDOSAGE

OVERDOSAGE SECTION

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.

In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels.

Treatment of hyperkalemia includes the following:

  1. Dextrose Injection USP, 10% or 25% containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour.
  2. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema.
  3. Hemodialysis and peritoneal dialysis. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

This solution is for intravenous use.

Dosage is to be directed by a physician and is dependent upon age, weight, clinical condition of the patient and laboratory determinations. Frequent laboratory determinations and clinical evaluation are essential to monitor changes in blood glucose and electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy.

When a hypertonic solution is to be administered peripherally, it should be slowly infused through a small bore needle, placed well within the lumen of a large vein to minimize venous irritation. Carefully avoid infiltration.

In the average adult, daily requirements of sodium and chloride are met by the infusion of one liter of 0.9% sodium chloride (154 mEq each of sodium and chloride).

Usually up to 40 mEq of potassium per liter daily is sufficient to replace normal loss in adults. Infusion rates should not exceed 10 mEq per hour or 120 mEq per day. A liter of fluid containing 40 mEq of potassium should be administered over an 8-hour period.

Fluid administration should be based on calculated maintenance or replacement fluid requirements for each patient.

Pediatric Dosage and Administration. There is no specific pediatric dose. The dose is dependent on weight, clinical condition and laboratory results.

See WARNINGS and PRECAUTIONS.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

HOW SUPPLIED SECTION

Potassium Chloride in 0.9% Sodium Chloride Injection is supplied sterile and nonpyrogenic in single-dose EXCEL® Containers packaged 12 per case. 

NDC REF  Size
20 mEq Potassium Chloride in 0.9% Sodium Chloride Injection
(20 mEq K+/L)
     0264-7865-00 L8650 1000 mL

STORAGE AND HANDLING SECTION

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

SPL UNCLASSIFIED SECTION

Rx only

Revised: December 2025

EXCEL is a registered trademark of B. Braun Medical Inc.

Directions for Use of EXCEL Container

SPL PATIENT PACKAGE INSERT SECTION

Caution: Do not use plastic containers in series connection.

To Open

Keep in overwrap until ready for use. Tear overwrap down at notch and remove solution container. Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found. If supplemental medication is desired, follow directions below before preparing for administration.

Note: Before use, perform the following checks:

           Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.

           Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. 
           Any container which is suspect should not be used.

           Use only if solution is clear and container is undamaged.

Preparation for Administration

  1. Remove plastic protector from sterile set port at bottom of container.
  2. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

Warning: Some additives may be incompatible.

To Add Medication Before Solution Administration

  1. Prepare medication site.
  2. Using syringe with 18–22 gauge needle, puncture medication port and inner diaphragm and inject.
  3. Squeeze and tap ports while ports are upright and mix solution and medication thoroughly.

To Add Medication During Solution Administration

  1. Close clamp on the set.
  2. Prepare medication site.
  3. Using syringe with 18–22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject.
  4. Remove container from IV pole and/or turn to an upright position.
  5. Evacuate both ports by tapping and squeezing them while container is in the upright position.
  6. Mix solution and medication thoroughly.
  7. Return container to in use position and continue administration.

SPL UNCLASSIFIED SECTION

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-003-111   LD-234-6

PRINCIPAL DISPLAY PANEL - 1000 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 mEq

POTASSIUM CHLORIDE IN

0.9% SODIUM CHLORIDE INJECTION

REF L8650

NDC 0264-7865-00

1000 mL

EXCEL® CONTAINER

20 mEq K+/L

Y94-003-519   LD-502-3

FOR INTRAVENOUS INFUSION

EACH 100 mL CONTAINS     SODIUM CHLORIDE USP 0.9 g

POTASSIUM CHLORIDE USP 0.15 g     WATER FOR

INJECTION USP QS     pH MAY BE ADJUSTED WITH HCL NF

pH 5.6 (3.5-6.5)     350 mOsmol/L (CALC)     HYPERTONIC

ELECTROLYTES (mEq/L)     NA+ 154     K+ 20     CL– 174

STERILE     SINGLE-DOSE     DISCARD UNUSED PORTION     

DO NOT USE IN SERIES CONNECTION     USE ONLY IF

SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED

WARNINGS     ADDITIVES MAY BE INCOMPATIBLE

CONSULT PHARMACIST     USE ASEPTIC TECHNIQUES

MIX THOROUGHLY     DO NOT STORE

STORE AT 20°C TO 25°C (68°F TO 77°F) [SEE USP CONTROLLED

ROOM TEMPERATURE]     AVOID EXCESSIVE HEAT

PROTECT FROM FREEZING     SEE PACKAGE INSERT

KEEP IN OVERWRAP UNTIL READY FOR USE     SQUEEZE AND

INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY

DISCARD IF LEAKS ARE FOUND

NOT MADE WITH NATURAL RUBBER LATEX PVC OR DEHP

 Not made with LatexNot made with Latex Not made with PVCNot made with PVC Not made with DEHPNot made with DEHP

Rx only

Other symbol
Other symbol

EXCEL IS A REGISTERED TRADEMARK OF B. BRAUN MEDICAL INC.

B. BRAUN MEDICAL INC.
BETHLEHEM, PA 18018-3524 USA
1-800-227-2862

Y94-003-518   LD-128-4

EXP
LOT

1000 mL Container Label L8650
1000 mL Container Label L8650

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637551potassium chloride 20 MEQ / sodium chloride 0.9 % in 1000 ML InjectionPSN14
6375511000 ML potassium chloride 0.02 MEQ/ML / sodium chloride 9 MG/ML InjectionSCD14
6375511000 ML K+ Chloride 0.02 MEQ/ML / NaCl 9 MG/ML InjectionSY14
6375511000 ML Pot Chloride 0.02 MEQ/ML / NaCl 9 MG/ML InjectionSY14
637551potassium chloride 20 MEQ / sodium chloride 0.9 % per 1000 ML InjectionSY14

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-7865-00POTASSIUM CHLORIDE IN SODIUM CHLORIDE1000 mL in 1 CONTAINERSOLUTION100014
0264-7865-00POTASSIUM CHLORIDE IN SODIUM CHLORIDE12 in 1 CASESOLUTION1214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-7865-00ML - Milliliter0264-7865f7cd40b4-9a65-4c49-83e5-ab5bf57db99a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I107
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X7
POTASSIUM CATIONACTIVE MOIETY295O53K1527
SODIUM CATIONACTIVE MOIETYLYR4M0NH377
WATERINACTIVE INGREDIENT059QF0KO0R7

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0264-78650264-7865-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019708-001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE37MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29
N019708-002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE75MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29
N019708-003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE110MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29
N019708-004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE150MG/100ML;900MG/100MLINJECTABLE / INJECTIONAP1989-09-29
N019708-005POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE220MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29
N019708-006POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDE300MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N019708-004AP

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 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N019708-001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER37MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29c2088c7a36db…
2026-10-15 13:18:302026-09N019708-002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER75MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29c2088c7a36db…
2026-10-15 13:18:302026-09N019708-003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER110MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29c2088c7a36db…
2026-10-15 13:18:302026-09N019708-004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER150MG/100ML;900MG/100MLINJECTABLE / INJECTIONAP1989-09-29c2088c7a36db…
2026-10-15 13:18:302026-09N019708-005POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER220MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29c2088c7a36db…
2026-10-15 13:18:302026-09N019708-006POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER300MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29c2088c7a36db…
2026-09-14 22:38:342026-08N019708-001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER37MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N019708-002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER75MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N019708-003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER110MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N019708-004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER150MG/100ML;900MG/100MLINJECTABLE / INJECTIONAP1989-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N019708-005POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER220MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N019708-006POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER300MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2984e616aacf4f…
2026-08-18 06:07:402026-07N019708-001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER37MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019708-002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER75MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019708-003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER110MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019708-004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER150MG/100ML;900MG/100MLINJECTABLE / INJECTIONAP1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019708-005POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER220MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019708-006POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER300MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019708-001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER37MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019708-002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER75MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019708-003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER110MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019708-004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER150MG/100ML;900MG/100MLINJECTABLE / INJECTIONAP1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019708-005POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER220MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019708-006POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER300MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019708-001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER37MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019708-002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER75MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019708-003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER110MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019708-004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER150MG/100ML;900MG/100MLINJECTABLE / INJECTIONAP1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019708-005POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER220MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019708-006POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER300MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019708-001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER37MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019708-002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER75MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019708-003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER110MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019708-004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER150MG/100ML;900MG/100MLINJECTABLE / INJECTIONAP1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019708-005POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER220MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019708-006POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER300MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019708-001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER37MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019708-002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER75MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019708-003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER110MG/100ML;900MG/100MLINJECTABLE / INJECTION1989-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019708-004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER150MG/100ML;900MG/100MLINJECTABLE / INJECTIONAP1989-09-29fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N019708-004AP1c2088c7a36db…
2026-09-14 22:38:342026-08N019708-004AP184e616aacf4f…
2026-08-18 06:07:402026-07N019708-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019708-004AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019708-004AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019708-004AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019708-004AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019708-004AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019708-004AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019708-004AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019708-004AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019708-004AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019708-004AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019708-004AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019708-004AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019708-004AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019708-004AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019708-004AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019708-004AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019708-004AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019708-004AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019708-004AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019708-004AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019708-004AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019708-004AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019708-004AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019708-004AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019708-004AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N019708-004AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019708-004AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019708-004AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019708-004AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019708-004AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019708-004AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019708-004AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019708-004AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019708-004AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019708-004AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019708-004AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019708-004AP13a93d1ddd44b…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE AND POTASSIUM CHLORIDEB. Braun Medical Inc.ecc38772-246a-46c4-b42a-b9b81124f27f2025-07-11Warnings, Adverse reactionsExact identifier
ndc (package): 0264-7865-00
ndc (product): 0264-7865
ndc11 (package): 00264786500
spl id: e0246dd9-bd3e-4e0d-bec9-cd6daf46683d
spl set id: ecc38772-246a-46c4-b42a-b9b81124f27f

Reported adverse events (FAERS/openFDA)#

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