eribulin mesylate

Generic: eribulin mesylate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eribulin mesylate
Generic Name eribulin mesylate
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eribulin mesylate .5 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3391
Product ID 0781-3391_d122f0a4-aff7-49f7-8cf1-06bc2883ad43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214310
Listing Expiration 2026-12-31
Marketing Start 2025-07-07

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813391
Hyphenated Format 0781-3391

Supplemental Identifiers

RxCUI
1045456
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 eribulin mesylate (source: ndc)
Generic Name eribulin mesylate (source: ndc)
Application Number ANDA214310 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0781-3391-94) / 2 mL in 1 VIAL
source: ndc

Packages (1)

Ingredients (1)

eribulin mesylate (.5 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "d122f0a4-aff7-49f7-8cf1-06bc2883ad43", "openfda": {"unii": ["AV9U0660CW"], "rxcui": ["1045456"], "spl_set_id": ["d122f0a4-aff7-49f7-8cf1-06bc2883ad43"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0781-3391-94)  / 2 mL in 1 VIAL", "package_ndc": "0781-3391-94", "marketing_start_date": "20250707"}], "brand_name": "Eribulin Mesylate", "product_id": "0781-3391_d122f0a4-aff7-49f7-8cf1-06bc2883ad43", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0781-3391", "generic_name": "eribulin mesylate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eribulin Mesylate", "active_ingredients": [{"name": "ERIBULIN MESYLATE", "strength": ".5 mg/mL"}], "application_number": "ANDA214310", "marketing_category": "ANDA", "marketing_start_date": "20250707", "listing_expiration_date": "20261231"}