NDC 25021-405

bivalirudin

Bivalirudin

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

Product ID25021-405_8d2a843f-68c9-48f4-ac50-7de7ab476dbf
NDC25021-405
Product TypeHuman Prescription Drug
Proprietary Namebivalirudin
Generic NameBivalirudin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA091602
Labeler NameSagent Pharmaceuticals
Substance NameBIVALIRUDIN
Active Ingredient Strength250 mg/1
Pharm ClassesAnti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 25021-405-05

10 VIAL in 1 CARTON (25021-405-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date2019-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-405-05 [25021040505]

bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA091602
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15
Marketing End Date2019-01-15

Drug Details

Active Ingredients

IngredientStrength
BIVALIRUDIN250 mg/1

OpenFDA Data

SPL SET ID:eb465d12-f1ec-4b84-bb42-a0abb09d2085
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
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