NDC 60505-6101

Bivalirudin

Bivalirudin

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

Product ID60505-6101_1181218a-a2a5-8f9a-ebdb-f5e31371ff38
NDC60505-6101
Product TypeHuman Prescription Drug
Proprietary NameBivalirudin
Generic NameBivalirudin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-07-17
Marketing CategoryANDA / ANDA
Application NumberANDA204876
Labeler NameApotex corp
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 60505-6101-4

10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6101-4) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-07-17
Marketing End Date2021-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-6101-4 [60505610104]

Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204876
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-17
Marketing End Date2021-03-01

Drug Details

Active Ingredients

IngredientStrength
BIVALIRUDIN250 mg/1

OpenFDA Data

SPL SET ID:3319d1ad-acaa-37dd-94cf-9c141c1f5545
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.