NDC Code(s) : 70518-0471-0, 70518-0471-1, 70518-0471-2
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ClopidogrelClopidogrel bisulphate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0471(NDC:16729-218)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOPIDOGREL BISULFATE(UNII: 08I79HTP27)
(CLOPIDOGREL - UNII:A74586SNO7) 		CLOPIDOGREL75 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color pink Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code CI
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70518-0471-090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/04/2017
2NDC:70518-0471-130 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/05/2019
3NDC:70518-0471-230 in 1 BLISTER PACK Type 0: Not a Combination Product01/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202925 04/28/2017

LABELER - REMEDYREPACK INC.(829572556)

PRINCIPAL DISPLAY PANEL

DRUG: Clopidogrel

GENERIC: Clopidogrel

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-0471-0

NDC: 70518-0471-1

NDC: 70518-0471-2

COLOR: pink

SHAPE: ROUND

SCORE: No score

SIZE: 9 mm

IMPRINT: CI

PACKAGING: 90 in 1 BOTTLE, PLASTIC

PACKAGING: 30 in 1 BOTTLE, PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CLOPIDOGREL BISULFATE 75mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
  • LACTOSE MONOHYDRATE
  • HYPROMELLOSE 2910 (15 MPA.S)
  • FERRIC OXIDE RED
  • TITANIUM DIOXIDE
  • TRIACETIN
  • HYDROGENATED CASTOR OIL
  • SILICON DIOXIDE

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