NDC 65862-829

Prasugrel

Prasugrel

Prasugrel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Prasugrel Hydrochloride.

Product ID65862-829_11f1a8af-65b5-4626-848c-85aba91c98a5
NDC65862-829
Product TypeHuman Prescription Drug
Proprietary NamePrasugrel
Generic NamePrasugrel
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-10-16
Marketing CategoryANDA / ANDA
Application NumberANDA205888
Labeler NameAurobindo Pharma Limited
Substance NamePRASUGREL HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesDecreased Platelet Aggregation [PE],P2Y12 Platelet Inhibitor [EPC],P2Y12 Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65862-829-03

3 BLISTER PACK in 1 CARTON (65862-829-03) > 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-829-10)
Marketing Start Date2017-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-829-30 [65862082930]

Prasugrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205888
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-16

NDC 65862-829-03 [65862082903]

Prasugrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205888
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-16

NDC 65862-829-10 [65862082910]

Prasugrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205888
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-16

Drug Details

Active Ingredients

IngredientStrength
PRASUGREL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:596c923d-db8d-4b96-bf31-52186a38c30d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855812
  • 855818
  • Pharmacological Class

    • Decreased Platelet Aggregation [PE]
    • P2Y12 Platelet Inhibitor [EPC]
    • P2Y12 Receptor Antagonists [MoA]

    Medicade Reported Pricing

    65862082930 PRASUGREL 5 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0378-5185PrasugrelPrasugrel
    0378-5186PrasugrelPrasugrel
    0440-0604PRASUGRELPrasugrel
    0440-0605PRASUGRELPrasugrel
    16729-272PrasugrelPrasugrel
    16729-273PrasugrelPrasugrel
    43817-239PrasugrelPrasugrel
    43817-240PrasugrelPrasugrel
    48792-7821prasugrelPrasugrel hydrochloride
    48792-7822prasugrelPrasugrel hydrochloride
    50090-4118PrasugrelPrasugrel
    50090-5169PrasugrelPrasugrel
    51407-247PrasugrelPrasugrel
    51407-248PrasugrelPrasugrel
    51407-444PrasugrelPrasugrel
    51407-445PrasugrelPrasugrel
    60505-4642PrasugrelPrasugrel
    60505-4643PrasugrelPrasugrel
    60687-412PrasugrelPrasugrel
    67877-604PRASUGRELPRASUGREL
    67877-605PRASUGRELPRASUGREL
    65162-001PrasugrelPrasugrel
    65162-002PrasugrelPrasugrel
    65862-829PrasugrelPrasugrel
    65862-830PrasugrelPrasugrel

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