68083-592 NDC - ERIBULIN MESYLATE

Drug Information

  • Product NDC: 68083-592
  • Proprietary Name: eribulin mesylate
  • Non Proprietary Name: eribulin mesylate
  • Active Ingredient(s): .5 mg/mL ERIBULIN MESYLATE
  • Administration Route(s): INTRAVENOUS
  • Dosage Form(s): INJECTION
  • Pharmacy Class(es): Microtubule Inhibition [PE]; Microtubule Inhibitor [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Gland Pharma Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA218047
Marketing Category: ANDA
Start Marketing Date:4/5/2024

Package Information

No. Package Code Package Description Billing Unit
168083-592-011 VIAL, SINGLE-DOSE in 1 CARTON (68083-592-01) / 2 mL in 1 VIAL, SINGLE-DOSE

NDC Record

Field Name Field Value Definition
PRODUCT NDC68083-592A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEeribulin mesylateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEeribulin mesylateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/5/2024The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
MARKETING CATEGORY NAMEANDAThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBERANDA218047A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
LABELER NAMEGland Pharma LimitedThis is the date that the labeler indicates was the start of its marketing of the drug product.
SUBSTANCE NAMEERIBULIN MESYLATEProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ACTIVE NUMERATOR STRENGTH.5This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ACTIVE INGRED UNITmg/mLName of Company corresponding to the labeler code segment of the Product NDC.
PHARM CLASSESMicrotubule Inhibition [PE], Microtubule Inhibitor [EPC]The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.

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This page was last updated on: 12/6/2025

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