NDC 25021-405

bivalirudin

Bivalirudin

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

• Product ID: 25021-405_8d2a843f-68c9-48f4-ac50-7de7ab476dbf
• NDC: 25021-405
• Product Type: Human Prescription Drug
• Proprietary Name: bivalirudin
• Generic Name: Bivalirudin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-01-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091602
• Labeler Name: Sagent Pharmaceuticals
• Substance Name: BIVALIRUDIN
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 25021-405-05

10 VIAL in 1 CARTON (25021-405-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• Marketing Start Date: 2019-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25021-405-05 [25021040505]

bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091602
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-15
• Marketing End Date: 2019-01-15

Drug Details

Active Ingredients

Ingredient	Strength
BIVALIRUDIN	250 mg/1

OpenFDA Data

• SPL SET ID: eb465d12-f1ec-4b84-bb42-a0abb09d2085
• Manufacturer:
  • Sagent Pharmaceuticals
• UNII:
  • TN9BEX005G
• 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"

NDC	Brand Name	Generic Name
0409-8300	Bivalirudin	BIVALIRUDIN
0781-3158	bivalirudin	bivalirudin
0781-9158	bivalirudin	bivalirudin
16729-275	Bivalirudin	Bivalirudin
25021-405	bivalirudin	bivalirudin
52958-034	Bivalirudin	Bivalirudin
55111-652	Bivalirudin	Bivalirudin
55150-210	BIVALIRUDIN	BIVALIRUDIN
60505-6101	Bivalirudin	bivalirudin
63323-562	Bivalirudin	Bivalirudin
67457-256	Bivalirudin	bivalirudin
69097-601	bivalirudin	bivalirudin
70511-141	bivalirudin	bivalirudin
70860-402	Bivalirudin	Bivalirudin
72572-035	bivalirudin	bivalirudin
71288-427	BIVALIRUDIN	BIVALIRUDIN
0781-3447	Angiomax	bivalirudin
65293-001	Angiomax	bivalirudin