Clopidogrel

CLOPIDOGREL- clopidogrel bisulfate tablet, film coated
Cadila Healthcare Limited

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
(click image for full-size original)
CLOPIDOGREL
clopidogrel tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1062
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
CITRIC ACID MONOHYDRATE
CROSPOVIDONE (15 MPA.S AT 5%)
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
HYDROGENATED CASTOR OIL
TITANIUM DIOXIDE
FERRIC OXIDE RED
STARCH, CORN
Product Characteristics
Color PINK (PINK) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 379
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1062-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1062-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1062-5 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1062-0 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201686 02/08/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1062), MANUFACTURE (70771-1062)

Revised: 08/2020 Cadila Healthcare Limited

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