Label: SODIUM CHLORIDE injection

  • NDC Code(s): 0338-9579-96, 0338-9583-96, 0338-9604-30, 0338-9608-24, view more
    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 March 31, 2019

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  • HEALTH CARE PROVIDER LETTER

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Sodium Chloride JB1301 Representative Container Label

    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

    Sodium Chloride JB1302 Representative Container Label

    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

    Sodium Chloride JB1322 Representative Container Label

    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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    Sodium Chloride JB1323 Representative Container Label

    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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    Sodium Chloride JB1324 Representative Container Label

    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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9579
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9579-9696 in 1 CARTON10/13/2017
    150 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage10/13/2017
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9583
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9583-9696 in 1 CARTON10/13/2017
    1100 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage10/13/2017
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9604
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9604-3030 in 1 CARTON10/13/201703/31/2019
    1250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage10/13/201703/31/2019
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9608
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9608-2424 in 1 CARTON10/13/201708/31/2019
    1500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage10/13/201708/31/2019
    SODIUM CHLORIDE 
    sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9612
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9612-1212 in 1 CARTON10/13/201710/31/2019
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug for use in drug shortage10/13/201710/31/2019
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Corporation205087968ANALYSIS(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)
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