NDC 70511-141

bivalirudin

Bivalirudin

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

Product ID70511-141_50aa9ddb-2b42-4c1f-958d-979e341446e5
NDC70511-141
Product TypeHuman Prescription Drug
Proprietary Namebivalirudin
Generic NameBivalirudin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-08-08
Marketing CategoryNDA / NDA
Application NumberNDA211215
Labeler NameMAIA Pharmaceuticals, 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 70511-141-50

1 INJECTION, SOLUTION in 1 CARTON (70511-141-50)
Marketing Start Date2019-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70511-141-84 [70511014184]

bivalirudin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA211215
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-08

NDC 70511-141-50 [70511014150]

bivalirudin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA211215
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-08

Drug Details

Active Ingredients

IngredientStrength
BIVALIRUDIN250 mg/1

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.