halaven

Generic: eribulin mesylate

Labeler: eisai inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name halaven
Generic Name eribulin mesylate
Labeler eisai inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eribulin mesylate .5 mg/mL

Manufacturer
Eisai Inc.

Identifiers & Regulatory

Product NDC 62856-389
Product ID 62856-389_2c75a415-0b1e-4c36-8301-c50ac155d980
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201532
Listing Expiration 2026-12-31
Marketing Start 2010-11-15

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62856389
Hyphenated Format 62856-389

Supplemental Identifiers

RxCUI
1045456 1045460
UNII
AV9U0660CW

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name halaven (source: ndc)
Generic Name eribulin mesylate (source: ndc)
Application Number NDA201532 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-389-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

eribulin mesylate (.5 mg/mL)

Linked Drug Pages (1)

Halaven ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2c75a415-0b1e-4c36-8301-c50ac155d980", "openfda": {"unii": ["AV9U0660CW"], "rxcui": ["1045456", "1045460"], "spl_set_id": ["31ce4750-ded5-4a0b-95e9-f229fa6bc822"], "manufacturer_name": ["Eisai Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (62856-389-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "62856-389-01", "marketing_start_date": "20101115"}], "brand_name": "Halaven", "product_id": "62856-389_2c75a415-0b1e-4c36-8301-c50ac155d980", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "62856-389", "generic_name": "eribulin mesylate", "labeler_name": "Eisai Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Halaven", "active_ingredients": [{"name": "ERIBULIN MESYLATE", "strength": ".5 mg/mL"}], "application_number": "NDA201532", "marketing_category": "NDA", "marketing_start_date": "20101115", "listing_expiration_date": "20261231"}