0.9% Sodium Chloride Injection USP

Manufacturer
B. Braun Medical Inc.
Effective date
2022-02-23
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 20:40:11

Label at a glance#

ProductSodium Chloride
Active ingredientSODIUM CHLORIDE
Label structure17 sections

Indications and uses

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE  of drug additives to be administered in this manner.

Dosage and administration

This solution is for intravenous use only. Do not use plastic container 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. This solution is intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Partial Fill

DESCRIPTION

DESCRIPTION SECTION

Each mL of 0.9% Sodium Chloride Injection USP contains:

Sodium Chloride USP 9 mg; Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.5 (4.5–7.0)
Calculated Osmolarity: 310 mOsmol/liter
Concentration of Electrolytes (mEq/100 mL): Sodium 15.4 Chloride 15.4

This solution is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:

IngredientMolecular FormulaMolecular Weight
 Sodium Chloride USP NaCl 58.44

Not made with natural rubber latex, PVC or DEHP.

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that 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 has two ports, one is for the intravenous administration set and the other is a medication addition site. Each is covered by a tamperproof barrier. Refer to the Directions for Use  of the container to properly identify the ports.

No vapor barrier is necessary.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

0.9% Sodium Chloride Injection USP 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 the acid-base equilibrium of body fluid.

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

This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.

This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

This solution is contraindicated where the administration of sodium or chloride could be clinically detrimental.

WARNINGS

WARNINGS SECTION

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. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS 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 an alternative solution(s).

Sodium-containing solutions should be administered with caution to patients receiving corticosteroids or corticotropin, or to other salt-retaining patients. Care should be exercised in administering solutions containing sodium to patients with renal or cardiovascular insufficiency, with or without congestive heart failure, particularly if they are postoperative or elderly. See PRECAUTIONS, Geriatric Use.

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.

Laboratory Tests

LABORATORY TESTS SECTION

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.

Drug Interactions

DRUG INTERACTIONS SECTION

Sodium-containing solutions should be administered with caution to patients receiving cortiscosteroids or corticotrophin.

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

Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride Injection USP.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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

Pregnancy

PREGNANCY SECTION

Teratogenic Effects

TERATOGENIC EFFECTS SECTION

Pregnancy Category C

SPL UNCLASSIFIED SECTION

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

Labor and Delivery

LABOR & DELIVERY SECTION

Studies have not been conducted to evaluate the effects of Sodium Chloride Injection USP on labor and delivery. As reported in the literature, sodium chloride 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

Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Injection USP is administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness of sodium chloride injections in pediatric patients have not been established by adequate and well controlled trials, however, the use of Sodium Chloride solutions in the pediatric population is referenced in the medical literature. All Warnings, Precautions and Adverse Reactions described in this label apply to pediatric patients.

Geriatric Use

GERIATRIC USE SECTION

An evaluation of current literature revealed no clinical experience identifying differences in response 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 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.

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.

The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted.

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.

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

This solution is for intravenous use only.

Do not use plastic container 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.

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 and seals are intact.

As directed by a physician. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations.

There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. See PRECAUTIONS, Pediatric Use.

When using this product as a diluent or vehicle for administration of drug additives, consult the prescribing information of the drug to be used.

Addition of medication should be accomplished using aseptic technique in order to assure sterility.

Physicochemical studies have shown that the container and solution can withstand freezing.

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

0.9% Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in partial fill polyolefin containers. The 100/150 mL product is packaged 64 per case. The 50/100 mL product is packaged 84 per case. The 25/100 mL product is packaged 116 per case.

NDCREFFill/Container (mL)
 0.9% Sodium Chloride Injection USP
 0264-1800-36 S8004-5410 25/100
 0264-1800-31 S8004-5384 50/100
 0264-1800-32 S8004-5264 100/150

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

SPL UNCLASSIFIED SECTION

Rx only

Revised: October 2016

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

Directions For Use of PAB® Container

SPL PATIENT PACKAGE INSERT SECTION

Partial Additive Bag

Aseptic technique is required.

Caution: Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date.

Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact. Single dose container. Discard unused portion. Consult Package Insert for complete product information.

The physician should also be alert to the possibility of adverse reactions to drug additives diluted and administered from the plastic partial fill container. Prescribing information for drug additives to be administered in this manner should be consulted.

Do not use plastic container in series connection.

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.

Physicochemical studies have shown that the container and solution can withstand freezing.


1. Identify Two Ports (See Figure A).

Figure AFigure A

2. To Add Medication
Remove additive port closure: hold container below additive port and grasp cap between thumb and forefinger then flip cap upward (See Figure B). Swab exposed additive port. Using a syringe with 18 gauge or smaller needle, insert cannula through resealable additive port and add desired drug. Mix thoroughly.
Note: Partial fill bags have been designed to accept an overfill of up to 50 mL.

Figure B
Figure B

3. To Attach Administration Set
To aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure C Steps 1 and 2.

Figure CFigure C

4. Push spike through the diaphragm of the port (See Figure D). Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use.

Figure D
Figure D

When the container is to be used as a diluent and delivery system for intermittent intravenous administration of compatible drug additives, consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.

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

PAB® containers can be safely transported in a standard 6-inch carrier through a pneumatic tube system that is well maintained and running properly.

SPL UNCLASSIFIED SECTION

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

Y36-002-925   LD-224-5

PRINCIPAL DISPLAY PANEL - 25 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOT
EXP

0.9% Sodium Chloride
Injection USP

NDC 0264-1800-36
REF S8004-5410

25 mL Partial Fill
in 100 mL PAB® Container

Each mL contains: Sodium Chloride USP 9 mg; Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF
pH: 5.5 (4.5-7.0)                     Calc. Osmolarity: 310 mOsmol/liter
Electrolytes (mEq/25 mL):       Sodium 3.8    Chloride 3.8

Sterile, nonpyrogenic. Single dose container. For intravenous use only.
Use only if solution is clear and container and seals are intact.

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

Recommended Storage: Room temperature (25°C).
Avoid excessive heat. See Package Insert.

Not made with natural rubber latex, PVC or DEHP.

Rx only

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

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

Y94-003-353
LD-227-2

25 mL Container Label
25 mL Container Label

PRINCIPAL DISPLAY PANEL - 50 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOT
EXP

0.9% Sodium Chloride
Injection USP

NDC 0264-1800-31
REF S8004-5384

50 mL Partial Fill
in 100 mL PAB® Container

Each mL contains: Sodium Chloride USP 9 mg; Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF
pH: 5.5 (4.5-7.0)                  Calc. Osmolarity: 310 mOsmol/liter
Electrolytes (mEq/50 mL):    Sodium 7.7    Chloride 7.7

Sterile, nonpyrogenic. Single dose container. For intravenous use only.
Use only if solution is clear and container and seals are intact.

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

Recommended Storage: Room temperature (25°C).
Avoid excessive heat. See Package Insert.

Not made with natural rubber latex, PVC or DEHP.

Rx only

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

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

Y94-003-339
LD-226-A-2

50 mL Container Label
50 mL Container Label

PRINCIPAL DISPLAY PANEL - 100 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOT
EXP

0.9% Sodium Chloride
Injection USP

 NDC 0264-1800-32
REF S8004-5264

100 mL Partial Fill
in 150 mL
PAB® Container

Each mL contains:
Sodium Chloride USP 9 mg
Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF
pH: 5.5 (4.5-7.0)
Calc. Osmolarity: 310 mOsmol/liter

Electrolytes (mEq/100 mL): Sodium 15.4; Chloride 15.4

Sterile, nonpyrogenic. Single dose container.
For intravenous use only. Use only if solution is clear
and container and seals are intact.

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

Recommended Storage: Room temperature (25°C).
Avoid excessive heat. See Package Insert.

Not made with natural rubber latex, PVC or DEHP.

Rx only

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

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

Y94-003-337   
LD-225-A-2

100 mL Container Label
100 mL Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1807632sodium chloride 0.9 % in 100 ML InjectionPSN9
1807630sodium chloride 0.9 % in 25 ML InjectionPSN9
1807631sodium chloride 0.9 % in 50 ML InjectionPSN9
1807632100 ML sodium chloride 9 MG/ML InjectionSCD9
180763025 ML sodium chloride 9 MG/ML InjectionSCD9
180763150 ML sodium chloride 9 MG/ML InjectionSCD9
1807632100 ML NaCl 9 MG/ML InjectionSY9
180763025 ML NaCl 9 MG/ML InjectionSY9
180763150 ML NaCl 9 MG/ML InjectionSY9
1807632sodium chloride 0.9 % per 100 ML InjectionSY9
1807630sodium chloride 0.9 % per 25 ML InjectionSY9
1807631sodium chloride 0.9 % per 50 ML InjectionSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
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
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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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
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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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-1800-31Sodium Chloride50 mL in 1 CONTAINERINJECTION, SOLUTION509
0264-1800-31Sodium Chloride84 in 1 CASEINJECTION, SOLUTION849
0264-1800-32Sodium Chloride100 mL in 1 CONTAINERINJECTION, SOLUTION1009
0264-1800-32Sodium Chloride64 in 1 CASEINJECTION, SOLUTION649
0264-1800-36Sodium Chloride25 mL in 1 CONTAINERINJECTION, SOLUTION259
0264-1800-36Sodium Chloride116 in 1 CASEINJECTION, SOLUTION1169

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-1800SODIUM CHLORIDE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9Current NDC, Legacy NDC, 6 package rows20220224_cc14fafd-3dcd-4fc8-bdbd-6f355c375768.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-1800-31ML - Milliliter0264-180063985c0c-aa49-408a-a8dd-9b2f707fa26812012-07-24
0264-1800-32ML - Milliliter0264-1800b8fc8da7-f25e-4484-b06f-dd360262692812012-07-24
0264-1800-36ML - Milliliter0264-180027cff672-bb0e-4493-a423-67372899f79712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X7
SODIUM CATIONACTIVE MOIETYLYR4M0NH377
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB7
WATERINACTIVE INGREDIENT059QF0KO0R7

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0264-18000264-1800-36, 0264-1800-31, 0264-1800-32

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
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT

Source Document#

Source XML

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 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SOLUTION / INTRAVENOUS1037 mgExact identifier — unii+route+dosage form
4 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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017464-001AP

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017464-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N017464-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N017464-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017464-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017464-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017464-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017464-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017464-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017464-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017464-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017464-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017464-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017464-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017464-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017464-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017464-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017464-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017464-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017464-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017464-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017464-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017464-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017464-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017464-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N017464-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017464-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017464-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017464-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N017464-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017464-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017464-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017464-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017464-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017464-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017464-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017464-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017464-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017464-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017464-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017464-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017464-001AP1f41ea6bd6efb…

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
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.cc14fafd-3dcd-4fc8-bdbd-6f355c3757682022-02-23Warnings, Adverse reactionsExact identifier
ndc (package): 0264-1800-31
ndc (package): 0264-1800-36
ndc (package): 0264-1800-32
ndc (product): 0264-1800
ndc11 (package): 00264180032
ndc11 (package): 00264180031
ndc11 (package): 00264180036
spl id: 7d4ee37f-5016-422c-9f66-e675ae22c46a
spl set id: cc14fafd-3dcd-4fc8-bdbd-6f355c375768

Reported adverse events (FAERS/openFDA)#

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