Label: BENZTROPINE MESYLATE injection

  • NDC Code(s): 10858-011-01, 10858-011-05
  • Packager: Wintac Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 26, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC-10858-011-01

    Benztropine Mesylate

    Injection, USP

    2 mg/2 mL (1 mg/mL)

    For Intravenous or Intramuscular use

    2 mL Single Dose Vial

    Wintac Limited

    Rx only

    vial

    vial

    NDC 10858-011-05

    Benztropine Mesylate

    Injection, USP

    2 mg/2 mL (1 mg/mL)

    FOR INTRAVENOUS OR INTRAMUSCULAR USE

    Wintac Limited

    5 X 2 mL Single Dose Vials

    Rx only

    carton

    carton

  • INGREDIENTS AND APPEARANCE
    BENZTROPINE MESYLATE 
    benztropine mesylate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10858-011
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K) BENZTROPINE MESYLATE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10858-011-055 in 1 CARTON11/26/2020
    1NDC:10858-011-012 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09152511/26/2020
    Labeler - Wintac Limited (677236695)
    Registrant - Navinta LLC (130443810)