NDC 70436-025

bivalirudin

Bivalirudin

bivalirudin is a Intravenous Injection, Powder, Lyophilized, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Slate Run Pharmaceuticals, Llc. The primary component is Bivalirudin.

Product ID70436-025_c44f8757-1a09-ab1e-e053-2a95a90a44e1
NDC70436-025
Product TypeHuman Prescription Drug
Proprietary Namebivalirudin
Generic NameBivalirudin
Dosage FormInjection, Powder, Lyophilized, For Suspension
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-06-30
Marketing CategoryANDA /
Application NumberANDA213078
Labeler NameSlate Run Pharmaceuticals, 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 70436-025-80

1 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 VIAL, SINGLE-DOSE (70436-025-80)
Marketing Start Date2021-06-30
NDC Exclude FlagN
Sample Package?N

Drug Details

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.