Label: TRANEXAMIC ACID injection, solution

  • NDC Code(s): 14593-318-01
  • Packager: Emcure Pharmaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 28, 2024

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  • INDICATIONS AND USAGE

    Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 14593-318-01

    Tranexamic Acid Injection, USP

    1000 mg/10 mL

    (100 mg/mL)

    Intravenous Use Only

    Rx only

    10 mL Single-Dose Vial

    label
  • INGREDIENTS AND APPEARANCE
    TRANEXAMIC ACID 
    tranexamic acid injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:14593-318
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) TRANEXAMIC ACID1 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14593-318-0110 in 1 CARTON10/28/2024
    110 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20352110/28/2024
    Labeler - Emcure Pharmaceuticals Limited (916921919)
    Registrant - Emcure Pharmaceuticals Limited (916921919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Emcure Pharmaceuticals Limited675467924ANALYSIS(14593-318) , MANUFACTURE(14593-318) , PACK(14593-318) , LABEL(14593-318)