Label: BENZTROPINE MESYLATE injection

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated November 26, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!