Benztropine Mesylate

BENZTROPINE MESYLATE- benztropine mesylate injection
Wintac Limited

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
(click image for full-size original)

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
(click image for full-size original)

carton

BENZTROPINE MESYLATE
benztropine mesylate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10858-011
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10858-011-05 5 VIAL in 1 CARTON contains a VIAL (10858-011-01)
1 NDC:10858-011-01 2 mL in 1 VIAL This package is contained within the CARTON (10858-011-05)
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)

Revised: 11/2020 Wintac Limited

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