eribulin mesylate

Generic: eribulin mesylate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eribulin mesylate
Generic Name eribulin mesylate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eribulin mesylate .5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-592
Product ID 68083-592_5db5b24e-3893-4985-a658-731cb840eb76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218047
Listing Expiration 2026-12-31
Marketing Start 2024-04-05

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083592
Hyphenated Format 68083-592

Supplemental Identifiers

RxCUI
1045456
UPC
0368083592011
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 (68083-592-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-592-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-592-01) / 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": "5db5b24e-3893-4985-a658-731cb840eb76", "openfda": {"upc": ["0368083592011"], "unii": ["AV9U0660CW"], "rxcui": ["1045456"], "spl_set_id": ["f57835e2-4c53-4e93-b54b-7d7a5000ae3d"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-592-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-592-01", "marketing_start_date": "20240405"}], "brand_name": "eribulin mesylate", "product_id": "68083-592_5db5b24e-3893-4985-a658-731cb840eb76", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "68083-592", "generic_name": "eribulin mesylate", "labeler_name": "Gland Pharma Limited", "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": "20240405", "listing_expiration_date": "20261231"}