Label: SODIUM CHLORIDE injection, solution

  • NDC Code(s): 0338-9804-01, 0338-9804-40, 0338-9806-01, 0338-9806-12, view more
    0338-9810-01, 0338-9810-24
  • 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 21, 2024

If you are a consumer or patient please visit this version.

  • HEALTH CARE PROFESSIONAL LETTER

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    Please refer to the FDA approved package insert for the full prescribing information of the drug product as follows:
    • 0.9% Sodium Chloride Injection, USP (click https://www.dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=f55bd888-5e01-474d-871b-24654c070178&type=pdf&name=f55bd888-5e01-474d-871b-24654c070178)

    Reporting Adverse Events or Product Quality Issues
    To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1- 800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
    • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
    Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).

    To report product quality issues associated with these imported products, please contact Baxter Product Surveillance through Baxter Product Feedback Portal (https://productfeedback.baxter.com/)

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  • PACKAGE INSERT

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Sodium Chloride A6C1322 Representative Container Label.jpg

    Container Label

    Baxter Logo Trademark

    A6C1322

    SODIUM CHLORIDE INJECTION

    50

    100

    150

    200

    250ml
    0.9% Sodium Chloride

    [Strength] 250ml: 2.25g
    [Description] This product is a clear, colorless liquid
    [Dosage and Administration] Intravenous drip    See the package 
    insert for details 
    For details of [Indications], [Adverse Reactions],
    [Contraindications], and [Precautions], please refer to the
    package insert

    [Storage] Store in overwrap

    The solution should be clear and should be used
    up at one time
    Inspect the inner bag by squeezing it and discard 
    solution if leakage occurs
    License Number: H19994066

    AA

    [Drug Marketing Authorization Holder] [Manufacturer]
    Name: Baxter Healthcare (Shanghai) Co., Ltd.
    Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

    GTIN Barcode Area

    LOT
    MFG
    EXP

    Sodium Chloride A6C1323 Representative Container Label.jpg

    Container Label

    Baxter Logo Trademark

    A6C1323

    SODIUM CHLORIDE INJECTION

    100

    200

    300

    400

    500ml
    0.9% Sodium Chloride

    [Strength] 500ml: 4.5g
    [Description] This product is a clear, colorless liquid
    [Dosage and Administration] Intravenous drip    See the package 
    insert for details 
    For details of [Indications], [Adverse Reactions],
    [Contraindications], and [Precautions], please refer to the
    package insert

    [Storage] Store in overwrap

    The solution should be clear and should be used
    up at one time
    Inspect the inner bag by squeezing it and discard 
    solution if leakage occurs
    License Number: H19983148

    AA

    [Drug Marketing Authorization Holder] [Manufacturer]
    Name: Baxter Healthcare (Shanghai) Co., Ltd.
    Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

    GTIN Barcode Area

    LOT
    MFG
    EXP

    Sodium Chloride A6C1324 Representative Container Label.jpg

    Container Label

    Baxter Logo Trademark

    A6C1324

    SODIUM CHLORIDE INJECTION

    100

    200

    300

    400

    500

    600

    700

    800

    900

    1000ml
    0.9% Sodium Chloride

    [Strength] 1000ml: 9g
    [Description] This product is a clear, colorless liquid
    [Dosage and Administration] Intravenous drip    See the package 
    insert for details 
    For details of [Indications], [Adverse Reactions],
    [Contraindications], and [Precautions], please refer to the
    package insert

    [Storage] Store in overwrap

    The solution should be clear and should be used
    up at one time
    Inspect the inner bag by squeezing it and discard 
    solution if leakage occurs
    License Number: H19983149

    AA

    [Drug Marketing Authorization Holder] [Manufacturer]
    Name: Baxter Healthcare (Shanghai) Co., Ltd.
    Address: No. 388, Tingzhu Road, Jinshan District, Shanghai

    GTIN Barcode Area

    LOT
    MFG
    EXP

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9804
    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 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9804-4040 in 1 CARTON10/18/2024
    1NDC:0338-9804-01250 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 shortage10/18/2024
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9806
    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 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9806-1212 in 1 CARTON10/18/2024
    1NDC:0338-9806-011000 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 shortage10/18/2024
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9810
    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 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9810-2424 in 1 CARTON10/18/2024
    1NDC:0338-9810-01500 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 shortage10/18/2024
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare (Shanghai) Co. Ltd.527191860MANUFACTURE(0338-9804, 0338-9806, 0338-9810) , ANALYSIS(0338-9804, 0338-9806, 0338-9810) , LABEL(0338-9804, 0338-9806, 0338-9810) , PACK(0338-9804, 0338-9806, 0338-9810) , STERILIZE(0338-9804, 0338-9806, 0338-9810)