NDC Code(s) : 33342-060-07, 33342-060-15, 33342-060-12, 33342-060-10, 33342-060-44
Packager : Macleods Pharmaceuticals Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clopidogrel Clopidogrel TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:33342-060
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE(UNII: 92RU3N3Y1O)
CASTOR OIL(UNII: D5340Y2I9G)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK (Pink) Score no score
Shape ROUND (Circular) Size 10 mm
Flavor Imprint Code L11
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:33342-060-0730 in 1 BOTTLE Type 0: Not a Combination Product16/10/2012
2NDC:33342-060-15500 in 1 BOTTLE Type 0: Not a Combination Product16/10/2012
3NDC:33342-060-12100 in 1 BOX, UNIT-DOSE Type 0: Not a Combination Product16/10/2012
4NDC:33342-060-1090 in 1 BOTTLE Type 0: Not a Combination Product09/11/2014
5NDC:33342-060-441000 in 1 BOTTLE Type 0: Not a Combination Product05/12/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202928 10/16/2012

LABELER - Macleods Pharmaceuticals Limited(862128535)

Establishment
Name Address ID/FEI Business Operations
Macleods Pharmaceuticals Limited 676369519 ANALYSIS(33342-060), LABEL(33342-060), MANUFACTURE(33342-060), PACK(33342-060)

PRINCIPAL DISPLAY PANEL


30 Tablets Container.
NDC 33342-060-07
Clopidogrel Tablets USP
Rx only



505




90 Tablets Container.
NDC 33342-060-10
Clopidogrel Tablets USP
Rx only

505

500 Tablets Container.
NDC 33342-060-15
Clopidogrel Tablets USP
Rx only


505

1000 Tablets Container.
NDC 33342-060-44
Clopidogrel Tablets USP
Rx only


505

Blister pack of 100 tablets (10 x 10 Unit Dose).
NDC 33342-060-12
Clopidogrel Tablets USP
Rx only


505