NDC 0781-3158

bivalirudin

Bivalirudin

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

• Product ID: 0781-3158_1a07a375-7456-4e00-befe-07aaf2cdb4a3
• NDC: 0781-3158
• 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: 2015-06-15
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020873
• Labeler Name: Sandoz
• 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: 2019-12-31

Packaging

NDC 0781-3158-95

10 VIAL, SINGLE-USE in 1 CARTON (0781-3158-95) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-3158-94)

• Marketing Start Date: 2015-06-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3158-95 [00781315895]

bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA authorized generic
• Application Number: NDA020873
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-06-15

NDC 0781-3158-94 [00781315894]

bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA authorized generic
• Application Number: NDA020873
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-06-15

Drug Details

Active Ingredients

Ingredient	Strength
BIVALIRUDIN	250 mg/1

OpenFDA Data

• SPL SET ID: ce56f806-7845-429d-a1ce-c2dbf79b22eb
• Manufacturer:
  • Sandoz
• UNII:
  • TN9BEX005G
• RxNorm Concept Unique ID - RxCUI:
  • 308769
• UPC Code:
  • 0307813158943

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