BENZTROPINE MESYLATE (Page 2 of 2)

HOW SUPPLIED SECTION

Benztropine Mesylate Tablets, USP are available as follows:

0.5 mg: white, round, flat-faced beveled edge, scored tablets, debossed “2325” on one side and debossed “V” on the reverse side, supplied in bottles of 10, 100 and 1000.

1 mg: white, oval, scored tablets, debossed “2326” on one side and debossed “V” on the reverse side, supplied in bottles of 10, 100 and 1000.

2 mg: white, round, flat-faced beveled edge, scored tablets, debossed “2327” on one side and debossed “V” on the reverse side, supplied in bottles of 10, 100 and 1000.

Dispense in a well-closed container as defined in the USP.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206:1963–1965, Nov. 25, 1968.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

128
(click image for full-size original)

BENZTROPINE MESYLATE
benztropine mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-128(NDC:0603-2435)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 2 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 2327;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-128-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040715 01/01/2014
Labeler — DIRECT RX (079254320)
Establishment
Name Address ID/FEI Operations
DIRECT RX 079254320 repack (61919-128), relabel (61919-128)

Revised: 01/2020 DIRECT RX

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