NDC 55111-652

Bivalirudin

Bivalirudin

Bivalirudin is a Intracavernous Injection in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is Bivalirudin.

• Product ID: 55111-652_31e3dfc1-c6f1-e660-955a-cb8777e80ecc
• NDC: 55111-652
• Product Type: Human Prescription Drug
• Proprietary Name: Bivalirudin
• Generic Name: Bivalirudin
• Dosage Form: Injection
• Route of Administration: INTRACAVERNOUS
• Marketing Start Date: 2017-05-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201577
• Labeler Name: Dr. Reddy's Laboratories Limited
• 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 55111-652-37

10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) > 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)

• Marketing Start Date: 2017-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55111-652-07 [55111065207]

Bivalirudin INJECTION

• Marketing Category: ANDA
• Application Number: ANDA201577
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-05-31

NDC 55111-652-37 [55111065237]

Bivalirudin INJECTION

• Marketing Category: ANDA
• Application Number: ANDA201577
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-05-31

Drug Details

Active Ingredients

Ingredient	Strength
BIVALIRUDIN	250 mg/1

OpenFDA Data

• SPL SET ID: 19beb2ae-6064-3c24-fe50-0cee86896979
• Manufacturer:
  • Dr. Reddy's Laboratories Limited
• 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