Label: SODIUM CHLORIDE injection

  • NDC Code(s): 0641-0497-17, 0641-0497-25, 0641-6144-01, 0641-6144-25
  • Packager: West-Ward Pharmaceuticals Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 18, 2018

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  • SPL UNCLASSIFIED SECTION

    Rx only 

  • DESCRIPTION

    This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.

    Sodium Chloride Injection USP, 0.9% is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Its chloride and sodium ion concentrations are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment, pH 5.3 (4.5 to 7.0).

    Sodium chloride, USP occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium chloride is freely soluble in water. The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44.

  • CLINICAL PHARMACOLOGY

    Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance.

    The distribution and excretion of sodium (Na+) and chloride (Cl) are largely under the control of the kidney which maintains a balance between intake and output. The small volume of fluid and amount of sodium chloride provided by Sodium Chloride Injection USP, 0.9% when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants.

    Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

    Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

  • INDICATIONS AND USAGE

    This parenteral preparation indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. 

  • PRECAUTIONS

    General

    Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.

    Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. 

    Pregnancy

    Pregnancy Category C

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

    Pediatric Use

    The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. 

    Drug Interactions

    Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol.

    Consult with pharmacist, if available.  Use aseptic technique for entry and withdrawal from all containers.

    When diluting or dissolving drugs, mix thoroughly and use promptly.

    Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.

    Do not use unless the solution is clear and seal intact. Do not reuse single dose containers, discard unused portion. 

  • ADVERSE REACTIONS

    Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

  • OVERDOSAGE

    Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS

  • DOSAGE AND ADMINISTRATION

    The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.

    This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  • HOW SUPPLIED

    Sodium Chloride Injection USP, 0.9% is supplied in the following:

    2 mL vials packaged in carton of 25 vials (NDC 0641-0497-25)

    10 mL vials packaged in carton of 25 vials (NDC 0641-6144-25)

    Storage

    Store at 20° - 25°C (68°-77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Avoid freezing. 

  • SPL UNCLASSIFIED SECTION

    To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    For Product Inquiry call 1-877-845-0689.

    Manufactured by:

    West-Ward logo

    WEST-WARD
    PHARMACEUTICALS
    Eatontown, NJ 07724 USA

    August 2013

    462-679-01

  • PRINCIPAL DISPLAY PANEL

    NDC 0641-0497-17
    Rx only
    Sodium Chloride Injection USP, 0.9%
    0.308 mOsmol/mL

    PRESERVATIVE-FREE
    For use as a sterile diluent

    2 mL Single Dose Vial

    NDC 0641-0497-17 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 2 mL Single Dose Vial

    NDC 0641-0497-25
    Rx only
    Sodium Chloride Injection USP, 0.9%
    0.308 mOsmol/mL

    PRESERVATIVE-FREE
    For use as a sterile diluent
    25 x 2 mL Single Dose Vials
    Each mL contains sodium chloride 9 mg in
    Water for Injection; pH 4.5-7.0, may contain
    hydrochloric acid and/or sodium hydroxide
    for pH adjustment.
    Sterile, nonpyrogenic.
    Contains no preservative. Discard unused
    portion.
    For additional information, see package insert.
    Store at 20º-25ºC (68º-77ºF) [See USP
    Controlled Room Temperature].

    NDC 0641-0497-25 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 25 x 2 mL Single Dose Vials Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains for preservative. Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature].
  • PRINCIPAL DISPLAY PANEL

    NDC 0641-6144-01
    Rx only
    Sodium Chloride
    Injection USP, 0.9%
    0.308 mOsmol/mL

    PRESERVATIVE-FREE
    For use as a sterile diluent

    10 mL Single Dose Vial
    Each mL contains sodium
    chloride 9 mg in Water for
    Injection; pH 4.5-7.0, may
    contain hydrochloric acid
    and/or sodium hydroxide
    for pH adjustment.
    Sterile, nonpyrogenic.
    Contains no preservative.
    Discard unused portion.
    For additional information,
    see package insert.
    Store at 20º-25ºC (68º-77ºF)
    [See USP Controlled
    Room Temperature].

    NDC 0641-6144-01 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 10 mL Single Dose Vial Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative. Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. 

    NDC 0641-6144-25
    Rx only
    Sodium Chloride
    Injection USP, 0.9%
    0.308 mOsmol/mL

    PRESERVATIVE-FREE
    For use as a sterile diluent

    25 x 10 mL Single Dose Vials
    Each mL contains sodium chloride 9 mg in
    Water for Injection; pH 4.5-7.0, may contain
    hydrochloric acid and/or sodium hydroxide
    for pH adjustment.
    Sterile, nonpyrogenic.
    Contains no preservative. Discard unused portion.
    For additional information, see package insert.
    Store at 20º-25ºC (68º-77ºF) [See USP
    Controlled Room Temperature].

    NDC 0641-6144-25 Rx only Sodium Chloride Injection USP, 0.9% 0.308 mOsmol/mL PRESERVATIVE-FREE For use as a sterile diluent 25 x 10 mL Single Dose Vials Each mL contains sodium chloride 9 mg in Water for Injection; pH 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Sterile, nonpyrogenic. Contains no preservative. Discard unused portion. For additional information, see package insert. Store at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. 

  • SERIALIZATION IMAGE

    Layout 1

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0641-0497
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0641-0497-2525 in 1 CARTON09/24/2013
    1NDC:0641-0497-172 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20183309/24/2013
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0641-6144
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0641-6144-2525 in 1 CARTON09/24/2013
    1NDC:0641-6144-0110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20183309/24/2013
    Labeler - West-Ward Pharmaceuticals Corp. (946499746)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hikma Pharmaceuticals USA Inc.946499746ANALYSIS(0641-0497, 0641-6144) , LABEL(0641-0497, 0641-6144) , MANUFACTURE(0641-0497, 0641-6144) , PACK(0641-0497, 0641-6144)