NDC 70860-403

Bivalirudin RTU

Bivalirudin

Bivalirudin RTU is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Athenex Pharmaceutical Division, Llc.. The primary component is Bivalirudin.

• Product ID: 70860-403_e670c25e-1572-4492-a6b5-4f42ba4b389a
• NDC: 70860-403
• Product Type: Human Prescription Drug
• Proprietary Name: Bivalirudin RTU
• Generic Name: Bivalirudin
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-03-01
• Marketing Category: NDA / NDA
• Application Number: NDA211215
• Labeler Name: Athenex Pharmaceutical Division, LLC.
• Substance Name: BIVALIRUDIN
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70860-403-51

10 CARTON in 1 CARTON (70860-403-51) > 1 VIAL, SINGLE-DOSE in 1 CARTON (70860-403-50) > 50 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2020-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70860-403-51 [70860040351]

Bivalirudin RTU INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA211215
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-03-01

NDC 70860-403-50 [70860040350]

Bivalirudin RTU INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA211215
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2020-03-01

Drug Details

Active Ingredients

Ingredient	Strength
BIVALIRUDIN	5 mg/mL

OpenFDA Data

• SPL SET ID: 1ed8c822-6fe1-49c1-a59f-31a4c72818c8
• Manufacturer:
  • Athenex Pharmaceutical Division, LLC.
• UNII:
  • TN9BEX005G
• RxNorm Concept Unique ID - RxCUI:
  • 1997015

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
70860-403	Bivalirudin RTU	Bivalirudin RTU
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