0407-1413 NDC - OMNIPAQUE (IOHEXOL)

Drug Information

Product NDC: 0407-1413

Proprietary Name: OMNIPAQUE

Non Proprietary Name: Iohexol

Active Ingredient(s):
  • 300 mg/mL IOHEXOL


Administration Route(s): INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL

Dosage Form(s): INJECTION, SOLUTION

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

Labeler Information

Labeler Name: GE Healthcare Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA018956
Marketing Category: NDA
Start Marketing Date:12/26/1985

Package Information

No. Package Code Package Description Billing Unit
10407-1413-1010 VIAL, GLASS in 1 BOX (0407-1413-10) / 10 mL in 1 VIAL, GLASSML
20407-1413-4810 BOTTLE, PLASTIC in 1 BOX (0407-1413-48) / 500 mL in 1 BOTTLE, PLASTICML
30407-1413-5310 BOTTLE, GLASS in 1 BOX (0407-1413-53) / 125 mL in 1 BOTTLE, GLASSML
40407-1413-5910 BOTTLE, PLASTIC in 1 BOX (0407-1413-59) / 30 mL in 1 BOTTLE, PLASTICML
50407-1413-6110 BOTTLE, PLASTIC in 1 BOX (0407-1413-61) / 50 mL in 1 BOTTLE, PLASTICML
60407-1413-6210 BOTTLE, PLASTIC in 1 BOX (0407-1413-62) / 75 mL in 1 BOTTLE, PLASTICML
70407-1413-6310 BOTTLE, PLASTIC in 1 BOX (0407-1413-63) / 100 mL in 1 BOTTLE, PLASTICML
80407-1413-6510 BOTTLE, PLASTIC in 1 BOX (0407-1413-65) / 150 mL in 1 BOTTLE, PLASTICML
90407-1413-6610 BOTTLE, PLASTIC in 1 BOX (0407-1413-66) / 200 mL in 1 BOTTLE, PLASTICML
100407-1413-6810 BOTTLE, PLASTIC in 1 BOX (0407-1413-68) / 500 mL in 1 BOTTLE, PLASTICML
110407-1413-6910 BOTTLE, PLASTIC in 1 BOX (0407-1413-69) / 125 mL in 1 BOTTLE, PLASTICML
120407-1413-7210 BOTTLE, PLASTIC in 1 BOX (0407-1413-72) / 500 mL in 1 BOTTLE, PLASTICML
130407-1413-8610 BOTTLE, PLASTIC in 1 BOX (0407-1413-86) / 50 mL in 1 BOTTLE, PLASTICML
140407-1413-8710 BOTTLE, PLASTIC in 1 BOX (0407-1413-87) / 100 mL in 1 BOTTLE, PLASTICML
150407-1413-8810 BOTTLE, PLASTIC in 1 BOX (0407-1413-88) / 150 mL in 1 BOTTLE, PLASTICML
160407-1413-8910 BOTTLE, PLASTIC in 1 BOX (0407-1413-89) / 500 mL in 1 BOTTLE, PLASTICML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0407-1413The 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 NAMEOmnipaqueThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEIohexolThe 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 NAMEINTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/3/2004This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020608This 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 NAMEGE Healthcare Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIOHEXOLAn 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 STRENGTH300 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 
PRODUCT NDC0407-1413The 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 NAMEOmnipaqueThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEIohexolThe 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 NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/21/2016This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020608This 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 NAMEGE HealthcareName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIOHEXOLAn 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 STRENGTH300 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 
PRODUCT NDC0407-1413The 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 NAMEOMNIPAQUEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEIohexolThe 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 NAMEINTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/21/2006This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA018956This 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 NAMEGE Healthcare Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIOHEXOLAn 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 STRENGTH300 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 
PRODUCT NDC0407-1413The 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 NAMEOmnipaqueThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEIohexolThe 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 NAMEINTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/21/2016This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020608This 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 NAMEGE HealthcareName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIOHEXOLAn 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 STRENGTH300 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 
PRODUCT NDC0407-1413The 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 NAMEOmnipaqueThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEIohexolThe 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 NAMEINTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/3/2005This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020608This 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 NAMEGE Healthcare Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIOHEXOLAn 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 STRENGTH300 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 
PRODUCT NDC0407-1413The 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 NAMEOMNIPAQUEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEIohexolThe 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 NAMEINTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/26/1985This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA018956This 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 NAMEGE Healthcare Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEIOHEXOLAn 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 STRENGTH300 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 

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