Benztropine Mesylate (Page 3 of 3)

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BENZTROPINE MESYLATE
benztropine mesylate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9729
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 9 mg in 1 mL
WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9729-05 5 AMPULE in 1 CARTON contains a AMPULE (0143-9729-01)
1 NDC:0143-9729-01 2 mL in 1 AMPULE This package is contained within the CARTON (0143-9729-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090287 09/01/2009
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)
Establishment
Name Address ID/FEI Operations
HIKMA FARMACEUTICA (PORTUGAL), S.A 452742943 manufacture (0143-9729)

Revised: 02/2022 Hikma Pharmaceuticals USA Inc.

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