NDC 60505-3532

Clopidogrel

Clopidogrel Bisulfate

Clopidogrel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Clopidogrel Bisulfate.

Product ID60505-3532_2f390e08-7999-65b9-0efa-12c0768eec91
NDC60505-3532
Product TypeHuman Prescription Drug
Proprietary NameClopidogrel
Generic NameClopidogrel Bisulfate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-03-04
Marketing CategoryANDA / ANDA
Application NumberANDA076274
Labeler NameApotex Corp.
Substance NameCLOPIDOGREL BISULFATE
Active Ingredient Strength300 mg/1
Pharm ClassesCytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 60505-3532-5

500 TABLET, FILM COATED in 1 BOTTLE (60505-3532-5)
Marketing Start Date2014-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-3532-0 [60505353200]

Clopidogrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076274
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-04
Marketing End Date2015-11-03

NDC 60505-3532-2 [60505353202]

Clopidogrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076274
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-04
Marketing End Date2015-11-03

NDC 60505-3532-5 [60505353205]

Clopidogrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076274
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-04

Drug Details

Active Ingredients

IngredientStrength
CLOPIDOGREL BISULFATE300 mg/1

OpenFDA Data

SPL SET ID:edae8df1-caf9-ff72-1304-5ae8b355f8e7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749196
  • 309362
  • Pharmacological Class

    • Decreased Platelet Aggregation [PE]
    • P2Y12 Platelet Inhibitor [EPC]
    • P2Y12 Receptor Antagonists [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]