NDC 65162-001

Prasugrel

Prasugrel

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

Product ID65162-001_0275550e-15e3-4c61-9b87-b88a0080d812
NDC65162-001
Product TypeHuman Prescription Drug
Proprietary NamePrasugrel
Generic NamePrasugrel
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-06-22
Marketing CategoryANDA / ANDA
Application NumberANDA205913
Labeler NameAmneal Pharmaceuticals LLC
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 65162-001-03

30 TABLET, FILM COATED in 1 BOTTLE (65162-001-03)
Marketing Start Date2018-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-001-03 [65162000103]

Prasugrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205913
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-22

Drug Details

Active Ingredients

IngredientStrength
PRASUGREL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:406cc201-89b6-43cc-9e14-a59327a5b4d8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855812
  • 855818
  • UPC Code
  • 0365162002034
  • 0365162001037
  • Pharmacological Class

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

    Medicade Reported Pricing

    65162000103 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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