0019-1323 NDC - OPTIRAY (IOVERSOL)

Drug Information

Product NDC: 0019-1323

Proprietary Name: Optiray

Non Proprietary Name: Ioversol

Active Ingredient(s):
  • 678 mg/mL IOVERSOL


Administration Route(s): INTRA-ARTERIAL; INTRAVENOUS

Dosage Form(s): INJECTION

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

Labeler Information

Labeler Name: Liebel-Flarsheim Company LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020923
Marketing Category: NDA
Start Marketing Date:11/18/2020

Package Information

No. Package Code Package Description Billing Unit
10019-1323-0020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-00) > 100 mL in 1 SYRINGE, PLASTICML
20019-1323-0225 VIAL, GLASS in 1 CARTON (0019-1323-02) > 20 mL in 1 VIAL, GLASSML
30019-1323-0425 VIAL, GLASS in 1 CARTON (0019-1323-04) > 30 mL in 1 VIAL, GLASSML
40019-1323-0625 BOTTLE, GLASS in 1 CARTON (0019-1323-06) > 50 mL in 1 BOTTLE, GLASSML
50019-1323-1112 BOTTLE, GLASS in 1 CARTON (0019-1323-11) > 100 mL in 1 BOTTLE, GLASSML
60019-1323-1612 BOTTLE, GLASS in 1 CARTON (0019-1323-16) > 150 mL in 1 BOTTLE, GLASSML
70019-1323-2112 BOTTLE, GLASS in 1 CARTON (0019-1323-21) > 200 mL in 1 BOTTLE, GLASSML
80019-1323-2720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-27) > 125 mL in 1 SYRINGE, PLASTICML
90019-1323-5220 SYRINGE, PLASTIC in 1 CARTON (0019-1323-52) > 50 mL in 1 SYRINGE, PLASTICML
100019-1323-5520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-55) > 50 mL in 1 SYRINGE, PLASTIC
110019-1323-616 BOTTLE, GLASS in 1 CARTON (0019-1323-61) > 500 mL in 1 BOTTLE, GLASSML
120019-1323-656 BOTTLE, GLASS in 1 CARTON (0019-1323-65) > 500 mL in 1 BOTTLE, GLASS
130019-1323-7020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-70) > 30 mL in 1 SYRINGE, PLASTICML
140019-1323-7320 SYRINGE, PLASTIC in 1 CARTON (0019-1323-73) > 30 mL in 1 SYRINGE, PLASTICML
150019-1323-7520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-75) > 50 mL in 1 SYRINGE, PLASTICML
160019-1323-7720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-77) > 50 mL in 1 SYRINGE, PLASTICML
170019-1323-7820 SYRINGE, PLASTIC in 1 CARTON (0019-1323-78) > 50 mL in 1 SYRINGE, PLASTICML
180019-1323-8120 SYRINGE, PLASTIC in 1 CARTON (0019-1323-81) > 125 mL in 1 SYRINGE, PLASTICML
190019-1323-8320 SYRINGE, PLASTIC in 1 CARTON (0019-1323-83) > 100 mL in 1 SYRINGE, PLASTICML
200019-1323-8520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-85) > 75 mL in 1 SYRINGE, PLASTICML
210019-1323-8720 SYRINGE, PLASTIC in 1 CARTON (0019-1323-87) > 125 mL in 1 SYRINGE, PLASTICML
220019-1323-9020 SYRINGE, PLASTIC in 1 CARTON (0019-1323-90) > 100 mL in 1 SYRINGE, PLASTICML
230019-1323-9120 SYRINGE, PLASTIC in 1 CARTON (0019-1323-91) > 75 mL in 1 SYRINGE, PLASTICML
240019-1323-9520 SYRINGE, PLASTIC in 1 CARTON (0019-1323-95) > 75 mL in 1 SYRINGE, PLASTICML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0019-1323The 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 NAMEOptirayThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX320A 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.
NON PROPRIETARY NAMEIoversolThe 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 NAMEINTRA-ARTERIAL; INTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/17/2011This 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 NUMBERNDA020923This 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 NAMEIOVERSOLThe following is the list of active ingredients in this product. An 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 STRENGTH678 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 
PRODUCT NDC0019-1323The 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 NAMEOptirayThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX320A 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.
NON PROPRIETARY NAMEIoversolThe 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 NAMEINTRA-ARTERIAL; INTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/4/2012This 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 NUMBERNDA019710This 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 NAMEIOVERSOLThe following is the list of active ingredients in this product. An 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 STRENGTH678 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 
PRODUCT NDC0019-1323The 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 NAMEOptirayThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX320A 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.
NON PROPRIETARY NAMEIoversolThe 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 NAMEINTRA-ARTERIAL; INTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE11/18/2020This 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 NUMBERNDA020923This 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 NAMEIOVERSOLThe following is the list of active ingredients in this product. An 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 STRENGTH678 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESRadiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 9/15/2022