NDC 16729-275

Bivalirudin

Bivalirudin

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

Product ID16729-275_7a71228f-1202-71cd-e053-2991aa0afc93
NDC16729-275
Product TypeHuman Prescription Drug
Proprietary NameBivalirudin
Generic NameBivalirudin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-07
Marketing CategoryANDA / ANDA
Application NumberANDA206551
Labeler NameAccord Healthcare, Inc.
Substance NameBIVALIRUDIN
Active Ingredient Strength250 mg/5mL
Pharm ClassesAnti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 16729-275-67

10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) > 5 mL in 1 VIAL, SINGLE-USE (16729-275-03)
Marketing Start Date2018-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-275-67 [16729027567]

Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206551
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-07

NDC 16729-275-03 [16729027503]

Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206551
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-07

Drug Details

Active Ingredients

IngredientStrength
BIVALIRUDIN250 mg/5mL

OpenFDA Data

SPL SET ID:c20969cb-72d4-469b-9bd8-332250d896c3
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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