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Drug Information

Product NDC: 0019-0953

Proprietary Name: Conray

Non Proprietary Name: iothalamate meglumine

Active Ingredient(s):

Administration Route(s): INTRAVASCULAR

Dosage Form(s): INJECTION

Pharmacy Class(es):
  • Radiographic Contrast Agent [EPC];
  • X-Ray Contrast Activity [MoA]

Labeler Information

Labeler Name: Liebel-Flarsheim Company LLC
FDA Application Number: NDA013295
Marketing Category: NDA
Start Marketing Date:10/14/2003

Package Information

No. Package Code Package Description Billing Unit
10019-0953-0525 VIAL, GLASS in 1 BOX (0019-0953-05) / 50 mL in 1 VIAL, GLASSML
20019-0953-1012 BOTTLE, GLASS in 1 BOX (0019-0953-10) / 100 mL in 1 BOTTLE, GLASS
30019-0953-2325 VIAL, GLASS in 1 BOX (0019-0953-23) / 30 mL in 1 VIAL, GLASSML
40019-0953-5012 BOTTLE, GLASS in 1 BOX (0019-0953-50) / 150 mL in 1 BOTTLE, GLASSML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0019-0953The 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 NAMEConrayThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEiothalamate meglumineThe 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 NAMEINTRAVASCULARThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/14/2003This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 under Structured Product Labeling Resources.
APPLICATION NUMBERNDA013295This 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.
LABELER NAMELiebel-Flarsheim Company LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIOTHALAMATE MEGLUMINEAn 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.
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 

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