NDC 60687-412

Prasugrel

Prasugrel

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

Product ID60687-412_84b2b689-476b-3828-e053-2a91aa0ab7c4
NDC60687-412
Product TypeHuman Prescription Drug
Proprietary NamePrasugrel
Generic NamePrasugrel
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA205897
Labeler NameAmerican Health Packaging
Substance NamePRASUGREL HYDROCHLORIDE
Active Ingredient Strength10 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 60687-412-21

30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-412-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-412-11)
Marketing Start Date2020-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-412-21 [60687041221]

Prasugrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205897
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 60687-412-11 [60687041211]

Prasugrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205897
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

Drug Details

Active Ingredients

IngredientStrength
PRASUGREL HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:543ae203-a8c1-4283-be97-8fd35e33227d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855812

    • 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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