CLOPIDOGREL- clopidogrel tablet, film coated 
Cadila Healthcare Limited

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CLOPIDOGREL TABLETS

Manufactured by:

Cadila Healthcare Ltd.

India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1062-9 in bottle of 90 Tablets

Clopidogrel Tablets USP, 75 mg

Rx only

90 TABLETS

Clopidogrel Tablets, 75 mg
CLOPIDOGREL 
clopidogrel tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1062
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7) CLOPIDOGREL75 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (PINK) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 379
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1062-330 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2017
2NDC:70771-1062-990 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2017
3NDC:70771-1062-5500 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2017
4NDC:70771-1062-01000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20168602/08/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1062) , MANUFACTURE(70771-1062)

Revised: 8/2020
Document Id: 44775700-22b3-4c9a-93f9-a344d7c70068
Set id: 3216ebb5-00ab-403d-98e6-36c5963b1a2c
Version: 5
Effective Time: 20200818
 
Cadila Healthcare Limited