NDC 76519-1016

Clopidogrel

Clopidogrel

Clopidogrel is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company Inc. The primary component is Clopidogrel Bisulfate.

Product ID76519-1016_5df77934-8584-0707-e053-2991aa0a52e5
NDC76519-1016
Product TypeHuman Prescription Drug
Proprietary NameClopidogrel
Generic NameClopidogrel
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-11-06
Marketing CategoryANDA / ANDA
Application NumberANDA202928
Labeler NameH.J. Harkins Company Inc
Substance NameCLOPIDOGREL BISULFATE
Active Ingredient Strength75 mg/1
Pharm ClassesDecreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76519-1016-3

30 TABLET in 1 CONTAINER (76519-1016-3)
Marketing Start Date2017-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76519-1016-3 [76519101603]

Clopidogrel TABLET
Marketing CategoryANDA
Application NumberANDA202928
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-06
Inactivation Date2020-01-31

NDC 76519-1016-2 [76519101602]

Clopidogrel TABLET
Marketing CategoryANDA
Application NumberANDA202928
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-06
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

OpenFDA Data

SPL SET ID:5df77934-8583-0707-e053-2991aa0a52e5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309362
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Clopidogrel" or generic name "Clopidogrel"

    NDCBrand NameGeneric Name
    0093-7314ClopidogrelClopidogrel
    0615-7719ClopidogrelClopidogrel
    0615-8014Clopidogrelclopidogrel bisulfate
    0904-6467Clopidogrelclopidogrel bisulfate
    16714-052ClopidogrelClopidogrel
    16729-218ClopidogrelClopidogrel bisulphate
    16729-219ClopidogrelClopidogrel bisulphate
    31722-901clopidogrelclopidogrel
    31722-902clopidogrelclopidogrel
    33261-987ClopidogrelClopidogrel Bisulfate
    33342-060ClopidogrelClopidogrel
    42543-713Clopidogrelclopidogrel
    42543-714Clopidogrelclopidogrel
    43547-484CLOPIDOGRELclopidogrel
    68071-1533ClopidogrelClopidogrel
    68071-1578ClopidogrelClopidogrel
    68071-3319ClopidogrelClopidogrel
    68071-4023ClopidogrelClopidogrel
    68071-4031ClopidogrelClopidogrel
    68071-4138ClopidogrelClopidogrel
    68084-536ClopidogrelClopidogrel
    68084-752ClopidogrelClopidogrel
    68645-430ClopidogrelClopidogrel
    68788-6324ClopidogrelClopidogrel
    69367-194ClopidogrelClopidogrel
    70518-0400ClopidogrelClopidogrel
    70518-0471ClopidogrelClopidogrel
    70518-0991clopidogrelclopidogrel
    70518-0750ClopidogrelClopidogrel
    70518-1510ClopidogrelClopidogrel
    70518-1898ClopidogrelClopidogrel
    70518-1383ClopidogrelClopidogrel
    70771-1062clopidogrelclopidogrel
    70710-1417clopidogrelclopidogrel
    70786-0060ClopidogrelClopidogrel
    70882-116ClopidogrelClopidogrel
    71205-073ClopidogrelClopidogrel
    71335-0581ClopidogrelClopidogrel
    71335-0080ClopidogrelClopidogrel
    71717-101CLOPIDOGRELCLOPIDOGREL
    76519-1016ClopidogrelClopidogrel
    43547-485CLOPIDOGRELCLOPIDOGREL
    50090-2082ClopidogrelClopidogrel
    50090-2598ClopidogrelClopidogrel
    50436-9986ClopidogrelClopidogrel
    51407-032ClopidogrelClopidogrel
    53002-1672ClopidogrelClopidogrel
    53808-1025ClopidogrelClopidogrel
    53808-1031ClopidogrelClopidogrel
    53808-0616ClopidogrelClopidogrel

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