NDC 69097-601

bivalirudin

Bivalirudin

bivalirudin is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Bivalirudin.

Product ID69097-601_3cb40f48-0c9d-42f4-8d72-57b3affca50e
NDC69097-601
Product TypeHuman Prescription Drug
Proprietary Namebivalirudin
Generic NameBivalirudin
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-07-16
Marketing CategoryANDA / ANDA
Application NumberANDA091602
Labeler NameCipla USA Inc.
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 69097-601-37

1 VIAL, SINGLE-USE in 1 CARTON (69097-601-37) > 1 INJECTION in 1 VIAL, SINGLE-USE
Marketing Start Date2018-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-601-37 [69097060137]

bivalirudin INJECTION
Marketing CategoryANDA
Application NumberANDA091602
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-16

NDC 69097-601-96 [69097060196]

bivalirudin INJECTION
Marketing CategoryANDA
Application NumberANDA091602
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-16

Drug Details

Active Ingredients

IngredientStrength
BIVALIRUDIN250 mg/1

OpenFDA Data

SPL SET ID:f7513fea-939a-4c74-b6e8-c5cb66620d1b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308769
    • UPC Code
  • 0369097601379
  • 0369097601966

    • 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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