NDC 63323-562

Bivalirudin

Bivalirudin

Bivalirudin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Bivalirudin.

• Product ID: 63323-562_218c6910-806b-430b-bbb9-a5129b1e1088
• NDC: 63323-562
• 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: 2016-10-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090189
• Labeler Name: Fresenius Kabi USA, LLC
• 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: 2021-12-31

Packaging

NDC 63323-562-15

10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)

• Marketing Start Date: 2017-10-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-562-10 [63323056210]

Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090189
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-28

NDC 63323-562-15 [63323056215]

Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090189
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-30

NDC 63323-562-41 [63323056241]

Bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090189
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-10-30

Drug Details

Active Ingredients

Ingredient	Strength
BIVALIRUDIN	250 mg/1

OpenFDA Data

• SPL SET ID: 50975be1-6d1f-497c-b989-1825a0fae1a7
• Manufacturer:
  • Fresenius Kabi USA, LLC
• 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