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FDA Drug information

SODIUM CHLORIDE

Read time: 1 mins
Marketing start date: 19 Apr 2025
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Summary of product characteristics


Effective Time

20241106

Version

6

Spl Product Data Elements

SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER SODIUM CHLORIDE sodium chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER

Brand Name

SODIUM CHLORIDE

Generic Name

sodium chloride

Product Ndc

0338-9608

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label JB1322 250 mL DIN 00060208 0.9% Sodium Chloride Injection USP Chlorure de Sodium à 0.9% USP, Injectable NaCl 0.9% 2D Barcode (01)00809080000562 APPROX mmol/L Na- 154 Cl - 154 mOsmol/L 308 APPROX pH 5.5 INTRAVENOUS FLUID AND ELEC- TROLYTE REPLENISHMENT / RET- ABLISSEMENT HYDRO-ELECTRO- LYTIQUE PAR INJECTION INTRA- VEINEUSE PER 100 mL SODIUM CHLORIDE USP - 900 mg / WATER FOR INJECTION USP - qs / WATER FOR INJECTION USP qs / pH MAY BE ADJUSTED WITH SODIUM HYDROXIDE PAR 100 mL CHORURE DE SODIUM USP - 900 mg / EAU POUR INJECTION USP - qs / pH PEUT ETRE AJUSTE AVEC DE L’HYDROXYDE DE SODIUM CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE AND INSPECT BAG / PRESCRIBING INFORMA- TION AVAILABLE UPON REQUEST / MUST NOT BE USED IN SERIES CONNECTIONS / STORE AT 15°C TO 25°C ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILI- SEE / PRESSER ET INSPECTER LE SAC / INFORMATION POSOLOGIQUE DISPONIBLE SUR DEMANDE / NE DOIT PAS ETRE MONTE EN SERIE / GARDER ENTRE 15°C ET 25°C NONPYROGENIC / STERILE APYROGENE VIAFLEX® PVC CONTAINER/CONTENANT DE PVC Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No LATEX Logo 88-70-20-415 50 100 150 200 Container Label JB1323 500 mL DIN 00060208 0.9% Sodium Chloride Injection USP Chlorure de Sodium à 0.9% USP, Injectable NaCl 0.9% APPROX mmol/L Na - 154 Cl - 154 mOsmol/L - 308 pH 5.5 INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT RETABLISSEMENT HYDRO-ELECTROLYTIQUE / PAR INJECTION INTRAVEINEUSE PER 100 mL SODIUM CHLORIDE USP - 900 mg / WATER FOR INJECTION USP – qs PAR 100 mL CHLORURE DE SODIUM USP - 900 mg / EAU POUR INJECTION USP - qs CAUTIONS SINGLE USE / DISCARD UNUSED PORTION / SQUEEZE AND INSPECT BAG / SEE DIRECTIONS FOR USE / MUST NOT BE USED IN SERIES CONNECTIONS / STORE AT 15° C TO 25° C ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER ET INSPECTER LE SAC / VOIR MODE D’EMPLOI / NE DOIT PAS ETRE MONTE EN SERIE / GARDER ENTRE 15° C ET 25° C NONPYROGENIC / STERILE / APYROGENE VIAFLEX PVC CONTAINER/ CONTENANT DE PVC BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No LATEX Label 07-25-77-317 1 _ 2 _ 3 _ 4 Container Label JB1324 1000 mL DIN 00060208 0.9% Sodium Chlo- ride Injection USP Chlorure de Sodium à 0.9% USP, Injectable NaCl 0.9% APPROX mmol/L Na - 154 Cl - 154 mOsmol/L - 308 pH 5.5 INTRAVENOUS FLUID AND ELECTROLYTE REPLENISHMENT / RETABLISSEMENT HYDRO- ELECTROLYTIQUE PAR INJECTION INTRAVEINEUSE PER 100 mL SODIUM CHLORIDE USP - 900 mg / WATER FOR INJECTION USP – qs PAR 100 mL CHLORURE DE SODIUM USP - 900 mg / EAU POUR INJECTION USP – qs CAUTIONS SINGLE USE / DISCARD UNUSED PORTION SQUEEZE AND INSPECT BAG / PRESCRIBING INFORMA- TION AVAILABLE UPON REQUEST / MUST NOT BE USED IN SERIES CONNECTIONS / STORE AT 15° C TO 25° C ATTENTIONS USAGE UNIQUE / JETER PORTION INUTILISEE / PRESSER ET INSPECTER LE SAC / INFOR- MATION POSOLOGIQUE DISPONIBLE SUR DEMANDE / NE DOIT PAS ETRE MONTE EN SERIE / GARDER ENTRE 15° C ET 25° C NONPYROGENIC / STERILE / APYROGENE VIAFLEX PVC CONTAINER / CONTENANT DE PVC BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC BAXTER ET VIAFLEX SONT DES MARQUES DE COMMERCE DE BAXTER INTERNATIONAL INC Baxter Logo Baxter Corporation Mississauga ON L5N 0C2 No LATEX Label 88-70-20-490 1 _ 2 _ 3 _ 4 _ 5 _ 6 _ 7 _ 8 _ 9 Container Label NDC 0338-9604-01 Container Label NDC 0338-9608-01 Container Label NDC 0338-9612-01

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