NDC 48792-7821

prasugrel

Prasugrel Hydrochloride

prasugrel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sunshine Lake Pharma Co., Ltd.. The primary component is Prasugrel Hydrochloride.

Product ID48792-7821_80a41613-454b-2f59-e053-2991aa0aacdf
NDC48792-7821
Product TypeHuman Prescription Drug
Proprietary Nameprasugrel
Generic NamePrasugrel Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-01-30
Marketing CategoryANDA / ANDA
Application NumberANDA206021
Labeler NameSunshine Lake Pharma Co., Ltd.
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 48792-7821-1

30 TABLET, FILM COATED in 1 BOTTLE (48792-7821-1)
Marketing Start Date2019-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48792-7821-1 [48792782101]

prasugrel TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206021
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-30

Drug Details

Active Ingredients

IngredientStrength
PRASUGREL HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:80a44606-523e-95c2-e053-2991aa0a574e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855812
  • 855818
  • UPC Code
  • 0348792782118
  • 0348792782217
  • 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 Hydrochloride"

    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
    67877-604PRASUGRELPRASUGREL
    67877-605PRASUGRELPRASUGREL
    60505-4642PrasugrelPrasugrel
    60505-4643PrasugrelPrasugrel
    60687-412PrasugrelPrasugrel
    65162-001PrasugrelPrasugrel
    65162-002PrasugrelPrasugrel
    65862-829PrasugrelPrasugrel
    65862-830PrasugrelPrasugrel
    51407-248PrasugrelPrasugrel
    51407-247PrasugrelPrasugrel
    51407-445PrasugrelPrasugrel
    0002-5121EffientPrasugrel hydrochloride
    0002-5123EffientPrasugrel hydrochloride
    0713-0881EffientPrasugrel Hydrochloride
    0713-0882EffientPrasugrel Hydrochloride

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