NDC Code(s) : 61786-013-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BENZTROPINE MESYLATEBENZTROPINE MESYLATE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-013(NDC:76385-103)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE(UNII: WMJ8TL7510)
(BENZTROPINE - UNII:1NHL2J4X8K) 		BENZTROPINE MESYLATE0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
TALC(UNII: 7SEV7J4R1U)
CORN OIL(UNII: 8470G57WFM)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code EP;136
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-013-0230 in 1 BLISTER PACK Type 0: Not a Combination Product28/08/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090168 08/28/2014 08/03/2017

PRINCIPAL DISPLAY PANEL

DRUG: BENZTROPINE MESYLATE

GENERIC: BENZTROPINE MESYLATE

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 61786-013-02

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 6 mm

IMPRINT: EP;136

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • BENZTROPINE MESYLATE 0.5mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE
  • ANHYDROUS LACTOSE
  • TALC
  • CELLULOSE, MICROCRYSTALLINE
  • CORN OIL
  • LACTOSE MONOHYDRATE
  • STARCH, CORN

/xml/0bd33841-6ae2-407d-92d7-015ea0ad7777/Remedy_Label.jpg