0270-1315 NDC - ISOVUE ()

Drug Information

  • Product NDC: 0270-1315
  • Proprietary Name: ISOVUE
  • Non Proprietary Name:
  • Active Ingredient(s): 612 mg/mL IOPAMIDOL612 mg/mL IOPAMIDOL
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Radiographic Contrast Agent [EPC]; X-Ray Contrast Activity [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Bracco Diagnostics Inc
Product Type:
FDA Application Number: NDA020327
Marketing Category: NDA
Start Marketing Date:10/12/1994
End Marketing Date:11/1/2021

Package Information

No. Package Code Package Description Billing Unit
10270-1315-2510 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-25) / 30 mL in 1 VIAL, SINGLE-DOSEML
20270-1315-3010 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30) / 50 mL in 1 VIAL, SINGLE-DOSEML
30270-1315-3510 BOTTLE in 1 BOX (0270-1315-35) / 100 mL in 1 BOTTLEML
40270-1315-4110 BOTTLE in 1 BOX (0270-1315-41) / 200 mL in 1 BOTTLEML
50270-1315-4510 BOTTLE in 1 BOX (0270-1315-45) / 200 mL in 1 BOTTLEML
60270-1315-4710 BOTTLE in 1 BOX (0270-1315-47) / 75 mL in 1 BOTTLEML
70270-1315-5010 BOTTLE in 1 BOX (0270-1315-50) / 150 mL in 1 BOTTLEML
80270-1315-956 BOTTLE in 1 BOX (0270-1315-95) / 500 mL in 1 BOTTLEML
90270-1315-986 BOTTLE in 1 BOX (0270-1315-98) / 500 mL in 1 BOTTLEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0270-1315The 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.
PROPRIETARY NAMEISOVUEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX300A 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.
START MARKETING DATE10/12/1994This 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 NUMBERNDA020327This 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 NAMEBracco Diagnostics IncName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0270-1315The 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.
PROPRIETARY NAMEISOVUEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX300A 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.
START MARKETING DATE12/31/1985This 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 NUMBERNDA018735This 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 NAMEBRACCO DIAGNOSTICS INCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0270-1315The 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.
PROPRIETARY NAMEISOVUEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX300A 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.
START MARKETING DATE6/20/2014This 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 NUMBERNDA020327This 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 NAMEBracco Diagnostics IncName of Company corresponding to the labeler code segment of the Product NDC.

Download Record

Download this NDC record record in Text format: Export

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

Download this NDC record record in XML format: Export

This page was last updated on: 7/4/2025

Previous Code
Next Code