Label: SODIUM CHLORIDE injection
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NDC Code(s):
0338-9604-01,
0338-9604-30,
0338-9608-01,
0338-9608-24, view more0338-9612-01, 0338-9612-12
- Packager: Baxter Healthcare Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Unapproved drug for use in drug shortage
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 6, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- HEALTH CARE PROVIDER LETTER
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
JB1322 250 mL DIN 00060208
0.9% Sodium Chloride Injection USP
Chlorure de Sodium à 0.9% USP, InjectableNaCl 0.9%
2D Barcode
(01)00809080000562APPROX mmol/L Na-154 Cl - 154
mOsmol/L 308APPROX pH 5.5
INTRAVENOUS FLUID AND ELEC-
TROLYTE REPLENISHMENT / RET-
ABLISSEMENT HYDRO-ELECTRO-
LYTIQUE PAR INJECTION INTRA-
VEINEUSEPER 100 mL SODIUM CHLORIDE USP - 900 mg / WATER
FOR INJECTION USP - qs / WATER FOR INJECTION USP
qs / pH MAY BE ADJUSTED WITH SODIUM HYDROXIDEPAR 100 mL CHORURE DE SODIUM USP - 900 mg / EAU
POUR INJECTION USP - qs / pH PEUT ETRE AJUSTE
AVEC DE L’HYDROXYDE DE SODIUMCAUTIONS 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°CNONPYROGENIC / STERILE APYROGENE
VIAFLEX® PVC CONTAINER/CONTENANT DE PVCBaxter Logo
Baxter Corporation
Mississauga ON L5N 0C2No LATEX Logo
88-70-20-41550
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JB1323 500 mL DIN 00060208
0.9% Sodium Chloride
Injection USP
Chlorure de Sodium à
0.9% USP, InjectableNaCl 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
INTRAVEINEUSEPER 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 - qsCAUTIONS 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° CATTENTIONS 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° CNONPYROGENIC / 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 INCBaxter Logo
Baxter Corporation
Mississauga ON L5N 0C2No LATEX Label
07-25-77-3171
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JB1324 1000 mL DIN 00060208
0.9% Sodium Chlo-
ride Injection USP
Chlorure de Sodium à
0.9% USP, InjectableNaCl 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 INTRAVEINEUSEPER 100 mL SODIUM CHLORIDE USP - 900 mg / WATER
FOR INJECTION USP – qsPAR 100 mL CHLORURE DE SODIUM USP - 900 mg / EAU
POUR INJECTION USP – qsCAUTIONS 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° CATTENTIONS 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° CNONPYROGENIC / 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 INCBaxter Logo
Baxter Corporation
Mississauga ON L5N 0C2No LATEX Label
88-70-20-4901
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INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
sodium chloride injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9604 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 900 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0338-9604-30 30 in 1 CARTON 10/13/2017 1 NDC:0338-9604-01 250 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug for use in drug shortage 10/13/2017 SODIUM CHLORIDE
sodium chloride injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9608 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 900 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0338-9608-24 24 in 1 CARTON 10/13/2017 1 NDC:0338-9608-01 500 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug for use in drug shortage 10/13/2017 SODIUM CHLORIDE
sodium chloride injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9612 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 900 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0338-9612-12 12 in 1 CARTON 10/13/2017 1 NDC:0338-9612-01 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug for use in drug shortage 10/13/2017 Labeler - Baxter Healthcare Corporation (005083209)
