BENZTROPINE MESYLATE- benztropine mesylate injection 
Wintac Limited

----------

Benztropine mesylate injection, USP

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

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)

Revised: 11/2020
Document Id: 67ef7746-45bc-466b-a7b7-353c8b8702c1
Set id: 357140ce-d84f-43e2-a106-bb2175f46417
Version: 1
Effective Time: 20201126
 
Wintac Limited