SODIUM CHLORIDE injection

SODIUM CHLORIDE by

Drug Labeling and Warnings

SODIUM CHLORIDE by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CARE PROVIDER LETTER

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

JB1301
50 mL

0.9%Sodium Chloride Injection USP

DIN 00060208
APPROX mmol/L Na - 154 Cl - 154
mOsmol/L 308 pH 5.5
SINGLE DOSE/DOSAGE UNIQUE

Barcode (01)00809080001040

PER/PAR mL SODIUM CHLORIDE USP / CHLORURE DE SODIUM USP - 9 mg pH MAY BE ADJUSTED WITH SODIUM HYDROXIDE / IV FLUID AND ELECTROLYTE REPLENISHER USE AS PRESCRIBED / PRESCRIBING INFORMATION AVAILABLE UPON REQUEST / SQUEEZE AND INSPECT BAG / DISCARD IF LEAKING / MUST NOT BE USED IN SERIES CONNECTIONS / STORE AT 15°C TO 25°C

pH PEUT ETRE AJUSTE AVEC DE L’HYDROXYDE DE SODIUM SOLUTION / IV AVEC ELECTROLYTES ADMINISTRER TEL QUE PRESCRIT PAR LE MEDECIN / INFORMATION POSOLOGIQUE DISPONIBLE SUR DEMANDE / PRESSER ET INSPECTER LE SAC / JETER EN CAS DE FUITES / 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
88-70-20-410

Container Label

JB1302
100 mL

0.9% Sodium Chloride Injection USP

DIN 00060208
APPROX mmol/L Na - 154 Cl -154
mOsmol/L 308 pH 5.5
SINGLE DOSE / DOSAGE UNIQUE

Barcode (01)00809080001057

PER/PAR mL SODIUM CHLORIDE USP/
CHLORURE DE SODIUM USP - 9 mg
pH MAY BE ADJUSTED WITH SODIUM
HYDROXIDE / IV FLUID AND ELECTRO-
LYTE REPLENISHER / USE AS PRE-
SCRIBED / PRESCRIBING INFORMA-
TION AVAILABLE UPON REQUEST /
SQUEEZE AND INSPECT BAG / DISCARD IF LEAKING /
MUST NOT BE USED IN SERIES CONNECTIONS / STORE
AT 15°C - 25°C

pH PEUT ETRE AJUSTE AVEC DE L’HYDROXYDE DE SODIUM / SO-
LUTION IV AVEC ELECTROLYTES /
ADMINISTRER TEL QUE PRESCRIT PAR LE MEDECIN / IN-
FORMATION POSOLOGIQUE DISPONIBLE SUR DEMANDE
PRESSER ET INSPECTER LE SAC / JETER EN CAS DE
FUITES / 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
88-70-20-411

Container Label

JB1322
250 mL
DIN 00060208
0.9% Sodium Chloride Injection USP
Chlorure de Sodium à 0.9% USP, Injectable

NaCl 0.9%
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

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100

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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

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 Logo
07-25-77-317

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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 Logo
88-70-20-490

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INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9579
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	9 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9579-96	96 in 1 CARTON	10/13/2017
1		50 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 injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9583
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	9 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9583-96	96 in 1 CARTON	10/13/2017
1		100 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 injection

Product 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	03/31/2019
1		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	03/31/2019

SODIUM CHLORIDE 
sodium chloride injection

Product 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	08/31/2019
1		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	08/31/2019

SODIUM CHLORIDE 
sodium chloride injection

Product 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	10/31/2019
1		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	10/31/2019

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Corporation		205087968	ANALYSIS(0338-9579, 0338-9583, 0338-9604, 0338-9608, 0338-9612) , LABEL(0338-9579, 0338-9583, 0338-9604, 0338-9608, 0338-9612) , MANUFACTURE(0338-9579, 0338-9583, 0338-9604, 0338-9608, 0338-9612) , PACK(0338-9579, 0338-9583, 0338-9604, 0338-9608, 0338-9612) , STERILIZE(0338-9579, 0338-9583, 0338-9604, 0338-9608, 0338-9612)