Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in the following: Unit of Sale Concentration NDC 14789-133-05 10 mL Single-dose glass vials in carton of 25 0.9% (10 mL) NDC 14789-134-05 20 mL Single-dose glass vials in carton of 25 0.9% (20 mL) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Manufactured in the USA by: Nexus Pharmaceuticals, LLC Lincolnshire, IL 60069 SCIPIR001 Revised: 12/2022; Principal Display Panel – 10 mL Carton Label NDC 14789-133-05 Rx Only 0.9% Sodium Chloride Injection, USP For Use as a Sterile Diluent Contains 25 x 10 mL Single-dose Vials NEXUS PHARMACEUTICALS sod19-0002-01; Principal Display Panel – 10 mL Vial Label NDC 14789-133-07 Rx Only 0.9% Sodium Chloride Injection, USP For Use as Sterile Diluent PRESERVATIVE-FREE 10 mL Single-dose Vial NEXUS PHARMACEUTICALS sod19-0002-02; Principal Display Panel – 20 mL Carton Label NDC 14789-134-05 Rx Only 0.9% Sodium Chloride Injection, USP For Use as a Sterile Diluent Contains 25 x 20 mL Single-dose Vials NEXUS PHARMACEUTICALS sod19-0002-03; Principal Display Panel – 20 mL Vial Label NDC 14789-134-07 Rx Only 0.9% Sodium Chloride Injection, USP For Use as Sterile Diluent PRESERVATIVE-FREE 20 mL Single-dose Vial Each mL contains sodium chloride, 9 mg. May contain HCl and/or NaOH for pH adjustment. Sterile, nonpyrogenic. 0.308 mOsmol/mL (calc) NEXUS PHARMACEUTICALS sod19-0002-04
- HOW SUPPLIED 0.9% Sodium Chloride Injection, USP is supplied in the following: Unit of Sale Concentration NDC 14789-133-05 10 mL Single-dose glass vials in carton of 25 0.9% (10 mL) NDC 14789-134-05 20 mL Single-dose glass vials in carton of 25 0.9% (20 mL) Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.] Manufactured in the USA by: Nexus Pharmaceuticals, LLC Lincolnshire, IL 60069 SCIPIR001 Revised: 12/2022
- Principal Display Panel – 10 mL Carton Label NDC 14789-133-05 Rx Only 0.9% Sodium Chloride Injection, USP For Use as a Sterile Diluent Contains 25 x 10 mL Single-dose Vials NEXUS PHARMACEUTICALS sod19-0002-01
- Principal Display Panel – 10 mL Vial Label NDC 14789-133-07 Rx Only 0.9% Sodium Chloride Injection, USP For Use as Sterile Diluent PRESERVATIVE-FREE 10 mL Single-dose Vial NEXUS PHARMACEUTICALS sod19-0002-02
- Principal Display Panel – 20 mL Carton Label NDC 14789-134-05 Rx Only 0.9% Sodium Chloride Injection, USP For Use as a Sterile Diluent Contains 25 x 20 mL Single-dose Vials NEXUS PHARMACEUTICALS sod19-0002-03
- Principal Display Panel – 20 mL Vial Label NDC 14789-134-07 Rx Only 0.9% Sodium Chloride Injection, USP For Use as Sterile Diluent PRESERVATIVE-FREE 20 mL Single-dose Vial Each mL contains sodium chloride, 9 mg. May contain HCl and/or NaOH for pH adjustment. Sterile, nonpyrogenic. 0.308 mOsmol/mL (calc) NEXUS PHARMACEUTICALS sod19-0002-04
Overview
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. 0.9% Sodium Chloride Injection, USP 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. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.3 (4.5 to 7.0). Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water. The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards.
Indications & Usage
This parenteral preparation is 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.
Dosage & 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.
Warnings & Precautions
No warnings available yet.
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.
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 single or multiple 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.
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