NDC Code(s) : 70518-0577-0, 70518-0577-1, 70518-0577-2, 70518-0577-4, 70518-0577-3
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:70518-0577(NDC:69315-137)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE(UNII: WMJ8TL7510)
(BENZTROPINE - UNII:1NHL2J4X8K) 		BENZTROPINE MESYLATE1 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 OVAL Size 10 mm
Flavor Imprint Code EP;137
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70518-0577-030 in 1 BLISTER PACK Type 0: Not a Combination Product19/06/2017
2NDC:70518-0577-128 in 1 BLISTER PACK Type 0: Not a Combination Product06/03/2020
3NDC:70518-0577-230 in 1 BLISTER PACK Type 0: Not a Combination Product06/09/2020
4NDC:70518-0577-3100 in 1 BOX 02/03/2022
4NDC:70518-0577-41 in 1 POUCH Type 0: Not a Combination Product06/09/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090168 06/19/2017

LABELER - REMEDYREPACK INC.(829572556)

PRINCIPAL DISPLAY PANEL

DRUG: BENZTROPINE MESYLATE

GENERIC: BENZTROPINE MESYLATE

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0577-0

NDC: 70518-0577-1

NDC: 70518-0577-2

NDC: 70518-0577-3

NDC: 70518-0577-4

COLOR: white

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 10 mm

IMPRINT: EP;137

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • BENZTROPINE MESYLATE 1mg in 1

INACTIVE INGREDIENT(S):

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

MM1

MM1

MM1

MM1