halaven

Generic: eribulin mesylate

Labeler: bsp pharmaceuticals spa
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name halaven
Generic Name eribulin mesylate
Labeler bsp pharmaceuticals spa
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eribulin mesylate .5 mg/mL

Manufacturer
BSP Pharmaceuticals SpA

Identifiers & Regulatory

Product NDC 43624-002
Product ID 43624-002_46b7876d-62f5-7a4f-e063-6394a90aa64a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201532
Listing Expiration 2026-12-31
Marketing Start 2017-04-21

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43624002
Hyphenated Format 43624-002

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
  • 100 TRAY in 1 BOX, UNIT-DOSE (43624-002-01) / 3 mL in 1 TRAY
source: ndc

Packages (1)

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

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": "46b7876d-62f5-7a4f-e063-6394a90aa64a", "openfda": {"unii": ["AV9U0660CW"], "rxcui": ["1045456", "1045460"], "spl_set_id": ["8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6"], "manufacturer_name": ["BSP Pharmaceuticals SpA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TRAY in 1 BOX, UNIT-DOSE (43624-002-01)  / 3 mL in 1 TRAY", "package_ndc": "43624-002-01", "marketing_start_date": "20170421"}], "brand_name": "Halaven", "product_id": "43624-002_46b7876d-62f5-7a4f-e063-6394a90aa64a", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "43624-002", "generic_name": "eribulin mesylate", "labeler_name": "BSP Pharmaceuticals SpA", "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": "20170421", "listing_expiration_date": "20261231"}