SODIUM CHLORIDE injection, solution
Sodium Chloride by
Drug Labeling and Warnings
Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by Nexus Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
-
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.
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.
-
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 0.9% Sodium Chloride Injection, USP 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
-
PRECAUTIONS
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:Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection, USP. 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.
-
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.
-
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 PRECAUTIONSand 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
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 250.9% (10 mL) NDC: 14789-134-05
20 mL Single-dose glass vials in carton of 250.9% (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, USPFor Use as a Sterile Diluent
Contains 25 x 10 mL Single-dose Vials
NEXUS
PHARMACEUTICALS
-
Principal Display Panel – 10 mL Vial Label
NDC: 14789-133-07
Rx Only
0.9% Sodium Chloride
Injection, USPFor Use as Sterile Diluent
PRESERVATIVE-FREE
10 mLSingle-dose Vial
NEXUS
PHARMACEUTICALS
-
Principal Display Panel – 20 mL Carton Label
NDC: 14789-134-05
Rx Only
0.9% Sodium Chloride
Injection, USPFor Use as a Sterile Diluent
Contains 25 x 20 mL Single-dose Vials
NEXUS
PHARMACEUTICALS
-
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 mLSingle-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
-
INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 14789-133 Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 14789-133-05 25 in 1 CARTON 10/31/2023 01/31/2026 1 NDC: 14789-133-07 10 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217535 10/31/2023 01/31/2026 SODIUM CHLORIDE
sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 14789-134 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 14789-134-05 25 in 1 CARTON 10/31/2023 02/28/2026 1 NDC: 14789-134-07 20 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217535 10/31/2023 02/28/2026 Labeler - Nexus Pharmaceuticals LLC (620714787) Establishment Name Address ID/FEI Business Operations Nexus Pharmaceuticals LLC 620714787 analysis(14789-133, 14789-134)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.