eribulin mesylate

Generic: eribulin mesylate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eribulin mesylate
Generic Name eribulin mesylate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

eribulin mesylate .5 mg/mL

Manufacturer
HIKMA PHARMACEUTICALS USA INC.

Identifiers & Regulatory

Product NDC 0143-9167
Product ID 0143-9167_44675218-d4b3-04bc-e063-6394a90a1fbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218281
Listing Expiration 2027-12-31
Marketing Start 2024-06-28

Pharmacologic Class

Classes
microtubule inhibition [pe] microtubule inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439167
Hyphenated Format 0143-9167

Supplemental Identifiers

RxCUI
1045456
UPC
0301439167013
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 ANDA218281 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9167-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0143-9167-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9167-01) / 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": "44675218-d4b3-04bc-e063-6394a90a1fbe", "openfda": {"upc": ["0301439167013"], "unii": ["AV9U0660CW"], "rxcui": ["1045456"], "spl_set_id": ["aa69e7a5-fa82-4984-b9d2-653c772b80e3"], "manufacturer_name": ["HIKMA PHARMACEUTICALS USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9167-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0143-9167-01", "marketing_start_date": "20240628"}], "brand_name": "ERIBULIN MESYLATE", "product_id": "0143-9167_44675218-d4b3-04bc-e063-6394a90a1fbe", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "0143-9167", "generic_name": "eribulin mesylate", "labeler_name": "HIKMA PHARMACEUTICALS USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERIBULIN MESYLATE", "active_ingredients": [{"name": "ERIBULIN MESYLATE", "strength": ".5 mg/mL"}], "application_number": "ANDA218281", "marketing_category": "ANDA", "marketing_start_date": "20240628", "listing_expiration_date": "20271231"}