56125-700 NDC - DIROXIMEL FUMARATE

Drug Information

  • Product NDC: 56125-700
  • Proprietary Name:
  • Non Proprietary Name: diroximel fumarate
  • Active Ingredient(s): 231 mg/1 DIROXIMEL FUMARATE
  • Administration Route(s):
  • Dosage Form(s): CAPSULE, DELAYED RELEASE

Labeler Information

Field Name Field Value
Labeler Name: Novo Nordisk Production Ireland Limited
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:10/29/2019

Package Information

No. Package Code Package Description Billing Unit
156125-700-001 BAG in 1 DRUM (56125-700-00) / 30000 CAPSULE, DELAYED RELEASE in 1 BAG

NDC Record

Field Name Field Value Definition
PRODUCT NDC56125-700The 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.
PRODUCT TYPE NAMEDRUG FOR FURTHER PROCESSINGIndicates 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.
NON PROPRIETARY NAMEdiroximel fumarateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, DELAYED RELEASEThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE10/29/2019This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct 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.
LABELER NAMENovo Nordisk Production Ireland LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDIROXIMEL FUMARATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH231 
ACTIVE INGRED UNITmg/1 

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

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