NDC 54458-888

Clopidogrel

Clopidogrel

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

Product ID54458-888_4e3ae543-f321-464c-a4c0-579ddd6cc462
NDC54458-888
Product TypeHuman Prescription Drug
Proprietary NameClopidogrel
Generic NameClopidogrel
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-12-02
Marketing CategoryANDA / ANDA
Application NumberANDA076999
Labeler NameInternational Laboratories, LLC
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 Through2020-12-31

Packaging

NDC 54458-888-16

30 TABLET, FILM COATED in 1 BOTTLE (54458-888-16)
Marketing Start Date2017-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54458-888-10 [54458088810]

Clopidogrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076999
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-02

NDC 54458-888-16 [54458088816]

Clopidogrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076999
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-22

Drug Details

Active Ingredients

IngredientStrength
CLOPIDOGREL BISULFATE75 mg/1

OpenFDA Data

SPL SET ID:3dd041b8-abf7-4e19-96bb-b3cc8b5603b5
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]

    Medicade Reported Pricing

    54458088816 CLOPIDOGREL 75 MG TABLET

    Pricing Unit: EA | Drug Type:

    54458088810 CLOPIDOGREL 75 MG TABLET

    Pricing Unit: EA | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.