eribulin mesylate

Generic: eribulin mesylate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eribulin mesylate
Generic Name eribulin mesylate
Labeler apotex corp.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eribulin mesylate .5 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6435
Product ID 60505-6435_69c87b29-2670-aa40-b36a-40df421adb14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218047
Listing Expiration 2026-12-31
Marketing Start 2025-03-19

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056435
Hyphenated Format 60505-6435

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 ANDA218047 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6435-0) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

60505-6435-0 1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6435-0) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

eribulin mesylate (.5 mg/mL)

Linked Drug Pages (1)

eribulin mesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "69c87b29-2670-aa40-b36a-40df421adb14", "openfda": {"unii": ["AV9U0660CW"], "rxcui": ["1045456"], "spl_set_id": ["64bf3c30-f06a-3615-ca5e-eb4154d371d0"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (60505-6435-0)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "60505-6435-0", "marketing_start_date": "20250319"}], "brand_name": "eribulin mesylate", "product_id": "60505-6435_69c87b29-2670-aa40-b36a-40df421adb14", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "60505-6435", "generic_name": "eribulin mesylate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "eribulin mesylate", "active_ingredients": [{"name": "ERIBULIN MESYLATE", "strength": ".5 mg/mL"}], "application_number": "ANDA218047", "marketing_category": "ANDA", "marketing_start_date": "20250319", "listing_expiration_date": "20261231"}