Clopidogrel: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

75 mg : 30 tablets

clopidogrel-75mg-30
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75 mg Blister

clopidogrel-75mg-blis
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75 mg Carton

clopidogrel-75mg-cart
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300 mg Blister

clopidogrel-300mg-blis
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300 mg Carton

clopidogrel-300mg-cart
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CLOPIDOGREL clopidogrel tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-218
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOPIDOGREL BISULFATE (CLOPIDOGREL) CLOPIDOGREL 75 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (15 MPA.S)
FERRIC OXIDE RED
TITANIUM DIOXIDE
TRIACETIN
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
Product Characteristics
Color pink Score no score
Shape ROUND Size 9mm
Flavor Imprint Code CI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-218-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-218-15 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-218-16 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:16729-218-46 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (16729-218-46)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202925 11/21/2013
CLOPIDOGREL clopidogrel tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-219
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOPIDOGREL BISULFATE (CLOPIDOGREL) CLOPIDOGREL 300 mg
Inactive Ingredients
Ingredient Name Strength
HYDROGENATED CASTOR OIL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (15 MPA.S)
FERRIC OXIDE RED
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color pink Score no score
Shape OVAL Size 18mm
Flavor Imprint Code CL
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-219-46 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (16729-219-46)
2 NDC:16729-219-75 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (16729-219-75)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202925 01/08/2015
Labeler — Accord Healthcare Inc. (604222237)
Registrant — Accord Healthcare Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 725927649 manufacture (16729-218), manufacture (16729-219), analysis (16729-218), analysis (16729-219)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 915837971 manufacture (16729-218), analysis (16729-218)

Revised: 01/2022 Accord Healthcare Inc.

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