Label: CLOPIDOGREL tablet, film coated
- NDC Code(s): 70771-1062-0, 70771-1062-3, 70771-1062-5, 70771-1062-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 3, 2023
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INGREDIENTS AND APPEARANCE
CLOPIDOGREL
clopidogrel tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1062 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7) CLOPIDOGREL 75 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (PINK) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 379 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1062-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2017 2 NDC:70771-1062-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2017 3 NDC:70771-1062-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2017 4 NDC:70771-1062-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201686 02/08/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1062) , MANUFACTURE(70771-1062)
