Label: LACTATED RINGERS- sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution

  • NDC Code(s): 0338-9832-01, 0338-9832-24
  • 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 December 3, 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:
    • Lactated Ringer’s Injection, USP (click https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dad7735c-709b-40ea-ab7a-15577e24a966)

    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/).

    DHCP Letter 3.jpg
    DHCP Letter 4.jpg
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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Lactated Ringer Representative Carton Label 500ml Chinese.jpg

    Baxter Logo Trademark

    A6E2323

    SODIUM LACTATE RINGER’S
    INJECTION

    100

    200

    300

    400

    500ml

    [Strength] 500ml
    Each 500ml contains 1.55g Sodium Lactate,
    3.00g Sodium Chloride, 0.15g Potassium Chloride, and 0.10g
    Calcium Chloride Dihydrate
    [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: H19983144

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

    LOT
    MFG
    EXP

  • INGREDIENTS AND APPEARANCE
    LACTATED RINGERS 
    sodium chloride, potassium chloride, sodium lactate and calcium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9832
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE600 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) SODIUM LACTATE310 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE30 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE20 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-9832-2424 in 1 CARTON12/03/2024
    1NDC:0338-9832-01500 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 shortage12/03/2024
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare (Shanghai) Co. Ltd.527191860ANALYSIS(0338-9832) , LABEL(0338-9832) , MANUFACTURE(0338-9832) , PACK(0338-9832) , STERILIZE(0338-9832)