NDC 62856-389

Halaven

Eribulin Mesylate

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

• Product ID: 62856-389_3547d687-4951-4423-9fce-64fdac8635ed
• NDC: 62856-389
• Product Type: Human Prescription Drug
• Proprietary Name: Halaven
• Generic Name: Eribulin Mesylate
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-11-15
• Marketing Category: NDA / NDA
• Application Number: NDA201532
• Labeler Name: Eisai Inc.
• 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: 2022-12-31

Packaging

NDC 62856-389-01

1 VIAL, SINGLE-DOSE in 1 CARTON (62856-389-01) > 2 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2010-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62856-389-01 [62856038901]

Halaven INJECTION

• Marketing Category: NDA
• Application Number: NDA201532
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-11-15

Drug Details

Active Ingredients

Ingredient	Strength
ERIBULIN MESYLATE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 31ce4750-ded5-4a0b-95e9-f229fa6bc822
• Manufacturer:
  • Eisai Inc.
• UNII:
  • AV9U0660CW
• RxNorm Concept Unique ID - RxCUI:
  • 1045456
  • 1045460

Pharmacological Class

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