NDC Code(s) : 43063-371-30, 43063-371-60, 43063-371-90
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clopidogrel BisulfateClopidogrel Bisulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-371(NDC:13668-141)
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)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink (light pink colored) Score no score
Shape ROUND (biconvex) Size 9 mm
Flavor Imprint Code 41
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43063-371-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product23/07/2012
2NDC:43063-371-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product23/07/2012
3NDC:43063-371-9090 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product23/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090844 05/17/2012

LABELER - PD-Rx Pharmaceuticals, Inc.(156893695)

REGISTRANT - PD-Rx Pharmaceuticals, Inc.(156893695)

Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-371)

PRINCIPAL DISPLAY PANEL

Clopidogrel Tablets, USP 75 mg

43063371 label