NDC 51079-558

Clopidogrel Bisulfate

Clopidogrel

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

Product ID51079-558_7df4a376-157d-655e-e053-2991aa0aff28
NDC51079-558
Product TypeHuman Prescription Drug
Proprietary NameClopidogrel Bisulfate
Generic NameClopidogrel
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-05-17
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA077665
Labeler NameMylan Institutional Inc.
Substance NameCLOPIDOGREL BISULFATE
Active Ingredient Strength300 mg/1
Pharm ClassesDecreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 51079-558-03

30 BLISTER PACK in 1 CARTON (51079-558-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-558-01)
Marketing Start Date2012-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-558-01 [51079055801]

Clopidogrel Bisulfate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077665
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Marketing End Date2019-08-31

NDC 51079-558-03 [51079055803]

Clopidogrel Bisulfate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077665
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-17
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
CLOPIDOGREL BISULFATE300 mg/1

OpenFDA Data

SPL SET ID:710bede3-2742-4413-8772-63b2a955fab5
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]

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

    NDCBrand NameGeneric Name
    0378-3627Clopidogrel Bisulfateclopidogrel
    0904-6294Clopidogrel BisulfateClopidogrel Bisulfate
    13668-141Clopidogrel BisulfateClopidogrel Bisulfate
    68071-4057Clopidogrel bisulfateClopidogrel bisulfate
    68071-4268Clopidogrel BisulfateClopidogrel Bisulfate
    68151-3118Clopidogrel bisulfateClopidogrel bisulfate
    68788-7238Clopidogrel BisulfateClopidogrel Bisulfate
    68788-9785Clopidogrel bisulfateClopidogrel bisulfate
    69117-1010Clopidogrel bisulfateClopidogrel bisulfate
    70400-101Clopidogrel bisulfateClopidogrel bisulfate
    70518-0195Clopidogrel BisulfateClopidogrel Bisulfate
    70518-0717Clopidogrel bisulfateClopidogrel bisulfate
    70518-0990Clopidogrel BisulfateClopidogrel Bisulfate
    70518-1079Clopidogrel BisulfateClopidogrel Bisulfate
    71399-7500Clopidogrel bisulfateClopidogrel bisulfate
    71335-0752Clopidogrel BisulfateClopidogrel Bisulfate
    43063-371Clopidogrel BisulfateClopidogrel Bisulfate
    43353-269clopidogrel bisulfateclopidogrel bisulfate
    47335-894Clopidogrel BisulfateClopidogrel Bisulfate
    50228-124Clopidogrel bisulfateClopidogrel bisulfate
    50228-121Clopidogrel bisulfateClopidogrel bisulfate
    51079-558Clopidogrel BisulfateClopidogrel Bisulfate
    53808-1002Clopidogrel bisulfateClopidogrel bisulfate
    53808-0806Clopidogrel BisulfateClopidogrel Bisulfate
    55154-3376Clopidogrel BisulfateClopidogrel Bisulfate
    55111-196Clopidogrel bisulfateClopidogrel bisulfate
    55111-671Clopidogrel bisulfateClopidogrel bisulfate
    55154-5388Clopidogrel BisulfateClopidogrel Bisulfate
    60429-301clopidogrel bisulfateclopidogrel bisulfate
    62034-017Clopidogrel bisulfateClopidogrel bisulfate
    62034-015clopidogrel bisulfateclopidogrel bisulfate
    63187-639Clopidogrel bisulfateClopidogrel bisulfate
    67046-099Clopidogrel bisulfateClopidogrel bisulfate
    50090-1300Clopidogrel BisulfateClopidogrel Bisulfate
    70518-2136Clopidogrel bisulfateClopidogrel bisulfate
    71335-1232Clopidogrel bisulfateClopidogrel bisulfate
    63629-8045Clopidogrel bisulfateClopidogrel bisulfate
    0093-7314ClopidogrelClopidogrel
    0615-7719ClopidogrelClopidogrel
    0615-8014Clopidogrelclopidogrel bisulfate
    0904-6467Clopidogrelclopidogrel bisulfate
    16714-052ClopidogrelClopidogrel
    16729-218ClopidogrelClopidogrel
    16729-219ClopidogrelClopidogrel
    31722-901clopidogrelclopidogrel
    31722-902clopidogrelclopidogrel
    33261-987ClopidogrelClopidogrel Bisulfate
    33342-060ClopidogrelClopidogrel
    0024-1171Plavixclopidogrel
    0024-1332Plavixclopidogrel

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