NDC 55150-210

BIVALIRUDIN

Bivalirudin

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

Product ID55150-210_840aa7a0-91c8-4a48-a248-c96e0dd1f5a5
NDC55150-210
Product TypeHuman Prescription Drug
Proprietary NameBIVALIRUDIN
Generic NameBivalirudin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-07-27
Marketing CategoryANDA / ANDA
Application NumberANDA205962
Labeler NameAuroMedics Pharma LLC
Substance NameBIVALIRUDIN
Active Ingredient Strength250 mg/1
Pharm ClassesAnti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55150-210-10

10 VIAL, SINGLE-DOSE in 1 CARTON (55150-210-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55150-210-10 [55150021010]

BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA205962
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-27

Drug Details

Active Ingredients

IngredientStrength
BIVALIRUDIN250 mg/1

OpenFDA Data

SPL SET ID:e574d04f-67b4-4a84-9d66-8c2d54f95120
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308769
    • UPC Code
  • 0355150210107

    • 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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