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Clopidogrel

These highlights do not include all the information needed to use CLOPIDOGREL TABLETS safely andeffectively. See full prescribing information for CLOPIDOGREL TABLETS. CLOPIDOGREL tablets, for oral useInitial U.S. Approval: 1997

Approved
Approval ID

3dd041b8-abf7-4e19-96bb-b3cc8b5603b5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 18, 2019

Manufacturers
FDA

International Laboratories, LLC

DUNS: 023569924

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clopidogrel

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54458-888
Application NumberANDA076999
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clopidogrel
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification

INGREDIENTS (15)

CLOPIDOGREL BISULFATEActive
Quantity: 75 mg in 1 1
Code: 08I79HTP27
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT

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Clopidogrel - FDA Drug Approval Details