Clopidogrel (Page 6 of 6)

Principal Display Panel

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-0253-2

Clopidogrel Tablets, USP

75 mg

Rx

90 count

Principal Display Panel

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-3992-3

Clopidogrel Tablets, USP

75 mg

Rx

30 count

Principal Display Panel

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-3532-5

300 mg

Rx only

500 Tablets

Principal Display Panel

Representative sample of labeling (see HOW SUPPLIED section for complete listing):

APOTEX CORP. NDC 60505-3532-2

300 mg

Rx only

30 Tablets

CLOPIDOGREL clopidogrel bisulfate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-0253 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 ANHYDROUS LACTOSE SILICON DIOXIDE CROSPOVIDONE (120 .MU.M) METHYLCELLULOSE (15 MPA.S) ZINC STEARATE FERRIC OXIDE RED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE

Product Characteristics Color PINK Score no score Shape ROUND Size 9mm Flavor Imprint Code APO;CL;75 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60505-0253-1 30 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:60505-0253-2 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:60505-0253-3 1000 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:60505-0253-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 4 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-0253-4) 5 NDC:60505-0253-5 76000 TABLET, FILM COATED in 1 PAIL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076274 05/17/2012

CLOPIDOGREL clopidogrel bisulfate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3992 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 ANHYDROUS LACTOSE SILICON DIOXIDE CROSPOVIDONE (120 .MU.M) METHYLCELLULOSE (15 MPA.S) ZINC STEARATE FERRIC OXIDE RED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE

Product Characteristics Color PINK Score no score Shape ROUND Size 9mm Flavor Imprint Code APO;CL;75 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60505-3992-3 30 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076274 05/17/2012 02/29/2020

CLOPIDOGREL clopidogrel bisulfate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3532 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 ANHYDROUS LACTOSE SILICON DIOXIDE CROSPOVIDONE (120 .MU.M) METHYLCELLULOSE (15 MPA.S) ZINC STEARATE FERRIC OXIDE RED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE

Product Characteristics Color PINK Score no score Shape CAPSULE (oblong) Size 9mm Flavor Imprint Code APO;CL300 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60505-3532-5 500 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076274 03/04/2014

Labeler — Apotex Corp. (845263701)

Registrant — Apotex Inc (209429182)

Revised: 05/2023 Apotex Corp.