NDC 0781-3447

Angiomax

Bivalirudin

Angiomax is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Bivalirudin.

• Product ID: 0781-3447_5f133813-f74e-4508-bc64-debbf104ff1e
• NDC: 0781-3447
• Product Type: Human Prescription Drug
• Proprietary Name: Angiomax
• Generic Name: Bivalirudin
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA020873
• Labeler Name: Sandoz Inc
• 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 0781-3447-95

10 VIAL, SINGLE-USE in 1 CARTON (0781-3447-95) > 1 INJECTION in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2019-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3447-95 [00781344795]

Angiomax INJECTION

• Marketing Category: NDA
• Application Number: NDA020873
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-01

Drug Details

Active Ingredients

Ingredient	Strength
BIVALIRUDIN	250 mg/1

OpenFDA Data

• SPL SET ID: 5f133813-f74e-4508-bc64-debbf104ff1e
• Manufacturer:
  • Sandoz Inc
• UNII:
  • TN9BEX005G
• RxNorm Concept Unique ID - RxCUI:
  • 284534
  • 308769

Pharmacological Class

• Anti-coagulant [EPC]
• Direct Thrombin Inhibitor [EPC]
• Thrombin Inhibitors [MoA]
• Anti-coagulant [EPC]
• Direct Thrombin Inhibitor [EPC]
• Thrombin Inhibitors [MoA]

NDC Crossover Matching brand name "Angiomax" or generic name "Bivalirudin"

NDC	Brand Name	Generic Name
0781-3447	Angiomax	bivalirudin
65293-001	Angiomax	bivalirudin
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