NDC Code(s) : 55154-6683-7, 55154-6683-4
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clopidogrelclopidogrel bisulfate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-6683(NDC:60505-0253)
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
METHYLCELLULOSE (15 MPA.S)(UNII: NPU9M2E6L8)
ZINC STEARATE(UNII: H92E6QA4FV)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code APO;CL;75
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-6683-4100 in 1 CARTON 17/05/2012
1NDC:55154-6683-71 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076274 05/17/2012 12/31/2016

PRINCIPAL DISPLAY PANEL

Clopidogrel

Tablet, USP

75 mg

lidding label

PRINCIPAL DISPLAY PANEL

Clopidogrel

Tablets, USP

75 mg

100 Tablets (10 x 10)

carton label

PRINCIPAL DISPLAY PANEL

Clopidogrel

Tablets, USP

75 mg

100 Tablets (10 x 10)

carton