NDC 0378-5185

Prasugrel

Prasugrel

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

Product ID0378-5185_2f3d4708-e019-425a-9bd0-b5de7e7366fd
NDC0378-5185
Product TypeHuman Prescription Drug
Proprietary NamePrasugrel
Generic NamePrasugrel
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-08-15
Marketing CategoryANDA / ANDA
Application NumberANDA205927
Labeler NameMylan 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 Through2021-12-31

Packaging

NDC 0378-5185-93

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5185-93)
Marketing Start Date2017-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5185-93 [00378518593]

Prasugrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-15

Drug Details

Active Ingredients

IngredientStrength
PRASUGREL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:41a4e332-6725-4cb7-940a-8291cf56cfe4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855812
  • 855818
  • UPC Code
  • 0303785185932
  • Pharmacological Class

    • 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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