76381-735 NDC - IOMERON (IOMEPROL INJECTION)

Drug Information

Product NDC: 76381-735

Proprietary Name: Iomeron

Non Proprietary Name: Iomeprol Injection

Active Ingredient(s):
  • 714 mg/mL IOMEPROL


Administration Route(s): INTRAVASCULAR

Dosage Form(s): INJECTION, SOLUTION

Labeler Information

Labeler Name: BIPSO GmbH
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Start Marketing Date:7/1/2022

Package Information

No. Package Code Package Description Billing Unit
176381-735-1056 BOTTLE, GLASS in 1 BOX (76381-735-10) / 100 mL in 1 BOTTLE, GLASS
276381-735-1530 BOTTLE, GLASS in 1 BOX (76381-735-15) / 150 mL in 1 BOTTLE, GLASS
376381-735-2010 BOTTLE, GLASS in 1 BOX (76381-735-20) / 200 mL in 1 BOTTLE, GLASS

NDC Record

Field Name Field Value Definition
PRODUCT NDC76381-735The 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 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 NAMEIomeronThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEIomeprol InjectionThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVASCULARThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/1/2022This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG FOR USE IN DRUG SHORTAGEProduct 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 NAMEBIPSO GmbHName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIOMEPROLAn 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 STRENGTH714 
ACTIVE INGRED UNITmg/mL 

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This page was last updated on: 2/1/2023