NDC 0440-0604

PRASUGREL

Prasugrel

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

Product ID0440-0604_60853d14-ac2a-4e48-9c0c-afd8069b83c6
NDC0440-0604
Product TypeHuman Prescription Drug
Proprietary NamePRASUGREL
Generic NamePrasugrel
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-10-17
Marketing CategoryANDA / ANDA
Application NumberANDA205790
Labeler NameLiberty Pharmaceuticals, Inc.
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 Through2020-12-31

Packaging

NDC 0440-0604-30

30 TABLET, FILM COATED in 1 BOTTLE (0440-0604-30)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0440-0604-30 [00440060430]

PRASUGREL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205790
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
PRASUGREL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:60853d14-ac2a-4e48-9c0c-afd8069b83c6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855812
  • 855818
  • Pharmacological Class

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

    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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