NDC 67457-256

Bivalirudin

Bivalirudin

Bivalirudin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Bivalirudin.

Product ID67457-256_19b96a1a-d0cd-45f5-9c7c-d3f60309cbdd
NDC67457-256
Product TypeHuman Prescription Drug
Proprietary NameBivalirudin
Generic NameBivalirudin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA202471
Labeler NameMylan Institutional LLC
Substance NameBIVALIRUDIN
Active Ingredient Strength250 mg/5mL
Pharm ClassesAnti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 67457-256-10

10 VIAL, SINGLE-DOSE in 1 CARTON (67457-256-10) > 5 mL in 1 VIAL, SINGLE-DOSE (67457-256-00)
Marketing Start Date2018-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-256-10 [67457025610]

Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202471
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-05

NDC 67457-256-00 [67457025600]

Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202471
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-05

Drug Details

Active Ingredients

IngredientStrength
BIVALIRUDIN250 mg/5mL

OpenFDA Data

SPL SET ID:95d150e7-f152-4091-b831-e469c9578a54
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308769

    • Pharmacological Class

    • Anti-coagulant [EPC]
    • Direct Thrombin Inhibitor [EPC]
    • Thrombin Inhibitors [MoA]

    NDC Crossover Matching brand name "Bivalirudin" or generic name "Bivalirudin"

    NDCBrand NameGeneric Name
    0409-8300BivalirudinBIVALIRUDIN
    0781-3158bivalirudinbivalirudin
    0781-9158bivalirudinbivalirudin
    16729-275BivalirudinBivalirudin
    25021-405bivalirudinbivalirudin
    52958-034BivalirudinBivalirudin
    55111-652BivalirudinBivalirudin
    55150-210BIVALIRUDINBIVALIRUDIN
    60505-6101Bivalirudinbivalirudin
    63323-562BivalirudinBivalirudin
    67457-256Bivalirudinbivalirudin
    69097-601bivalirudinbivalirudin
    70511-141bivalirudinbivalirudin
    70860-402BivalirudinBivalirudin
    72572-035bivalirudinbivalirudin
    71288-427BIVALIRUDINBIVALIRUDIN
    0781-3447Angiomaxbivalirudin
    65293-001Angiomaxbivalirudin
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.