Label: TRANEXAMIC ACID injection

  • NDC Code(s): 70771-1085-6
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    CONTAINER LABEL

    NDC 70771-1085-1

    Tranexamic Acid Injection

    1000 mg/10 mL

    (100 mg/mL)

    Solution for Intravenous Injection

    Discard any remaining portion after single use.

    10 mL Single-Dose Vial

    Rx only

    zydus pharmaceuticals

    figure02

    CARTON LABEL

    NDC 70771-1085-6

    Tranexamic Acid Injection

    1000 mg/10 mL

    (100 mg/mL)

    Solution for Intravenous Injection

    Discard any remaining portion after single use.

    10 X 10 mL Single-Dose Vials

    Rx only

    zydus pharmaceuticals

    figure03
  • INGREDIENTS AND APPEARANCE
    TRANEXAMIC ACID 
    tranexamic acid injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1085
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) TRANEXAMIC ACID100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1085-610 in 1 CARTON10/04/2017
    110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20522810/04/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1085) , MANUFACTURE(70771-1085)