NDC 43624-002

Halaven

Eribulin Mesylate

Halaven is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Bsp Pharmaceuticals Spa. The primary component is Eribulin Mesylate.

• Product ID: 43624-002_011afacd-c29f-4808-b38f-f113c1bb2717
• NDC: 43624-002
• Product Type: Human Prescription Drug
• Proprietary Name: Halaven
• Generic Name: Eribulin Mesylate
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-04-21
• Marketing Category: NDA / NDA
• Application Number: NDA201532
• Labeler Name: BSP Pharmaceuticals SpA
• Substance Name: ERIBULIN MESYLATE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Microtubule Inhibition [PE],Microtubule Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 43624-002-01

100 TRAY in 1 BOX, UNIT-DOSE (43624-002-01) > 3 mL in 1 TRAY

• Marketing Start Date: 2017-04-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43624-002-01 [43624000201]

Halaven INJECTION

• Marketing Category: NDA
• Application Number: NDA201532
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-04-21

Drug Details

Active Ingredients

Ingredient	Strength
ERIBULIN MESYLATE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6
• Manufacturer:
  • BSP Pharmaceuticals SpA
• UNII:
  • AV9U0660CW
• RxNorm Concept Unique ID - RxCUI:
  • 1045456
  • 1045460

Pharmacological Class

• Microtubule Inhibition [PE]
• Microtubule Inhibitor [EPC]

NDC Crossover Matching brand name "Halaven" or generic name "Eribulin Mesylate"

NDC	Brand Name	Generic Name
43624-002	Halaven	eribulin mesylate
62856-389	Halaven	eribulin mesylate