NDC 25208-001

AGGRASTAT

Tirofiban

AGGRASTAT is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Medicure International Inc. The primary component is Tirofiban Hydrochloride.

Product ID25208-001_13dda5a4-808b-427a-8cff-0d83e11e2bec
NDC25208-001
Product TypeHuman Prescription Drug
Proprietary NameAGGRASTAT
Generic NameTirofiban
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-10-15
Marketing CategoryNDA / NDA
Application NumberNDA020912
Labeler NameMedicure International Inc
Substance NameTIROFIBAN HYDROCHLORIDE
Active Ingredient Strength4 mg/15mL
Pharm ClassesDecreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 25208-001-04

1 VIAL, GLASS in 1 CARTON (25208-001-04) > 15 mL in 1 VIAL, GLASS
Marketing Start Date2016-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25208-001-04 [25208000104]

AGGRASTAT INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020912
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-15

Drug Details

Active Ingredients

IngredientStrength
TIROFIBAN HYDROCHLORIDE3.75 mg/15mL

OpenFDA Data

SPL SET ID:fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1737468
  • 1737466
  • 1737471
  • 1737472
  • 1813037
  • 1813035
  • Pharmacological Class

    • Decreased Platelet Aggregation [PE]
    • Platelet Aggregation Inhibitor [EPC]

    NDC Crossover Matching brand name "AGGRASTAT" or generic name "Tirofiban"

    NDCBrand NameGeneric Name
    25208-001AGGRASTATTIROFIBAN
    25208-002AGGRASTATTIROFIBAN
    68083-145Tirofiban hydrochlorideTirofiban

    Trademark Results [AGGRASTAT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AGGRASTAT
    AGGRASTAT
    86638878 5087529 Live/Registered
    Medicure International Inc.
    2015-05-22
    AGGRASTAT
    AGGRASTAT
    77040191 3441374 Live/Registered
    MEDICURE INTERNATIONAL, INC.
    2006-11-09
    AGGRASTAT
    AGGRASTAT
    74660332 2027788 Live/Registered
    MEDICURE INTERNATIONAL, INC.
    1995-04-10

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