BENZTROPINE MESYLATE injection

benztropine mesylate by

Drug Labeling and Warnings

benztropine mesylate by is a Prescription medication manufactured, distributed, or labeled by Wintac Limited, Navinta LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

BENZTROPINE MESYLATE 
benztropine mesylate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10858-011
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZTROPINE MESYLATE (UNII: WMJ8TL7510) (BENZTROPINE - UNII:1NHL2J4X8K)	BENZTROPINE MESYLATE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10858-011-05	5 in 1 CARTON	11/26/2020
1	NDC: 10858-011-01	2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091525	11/26/2020

Labeler - Wintac Limited (677236695)

Registrant - Navinta LLC (130443810)