NDC 0407-0690-40 Omniscan
Gadodiamide Injection Intravenous

Package Information

The NDC Code 0407-0690-40 is assigned to a package of 10 vial in 1 box > 15 ml in 1 vial of Omniscan, a human prescription drug labeled by Ge Healthcare Inc.. The product's dosage form is injection and is administered via intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 150 billable units per package.

Field Name Field Value
NDC Code 0407-0690-40
Package Description 10 VIAL in 1 BOX > 15 mL in 1 VIAL
Product Code 0407-0690
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Omniscan
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Gadodiamide
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
OMNISCAN is contraindicated in patients with:chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2), oracute kidney injuryprior hypersensitivity reaction to OMNISCAN
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
00407069040
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 150 ML
Product Type What kind of product is this?
Indicates 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.
Human Prescription Drug
Labeler Name Ge Healthcare Inc.
Dosage Form Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s)
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class(es)
Sample Package Sample Package?
This field Indicates whether this package is a sample packaging or not.
No
Marketing Category What is the Marketing Category?
Product 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.
NDA - A product marketed under an approved New Drug Application.
FDA Application Number What is the FDA Application Number?
This 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.
NDA022066
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-02-2007
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Omniscan with product NDC 0407-0690.

NDC Package CodePackage Description
0407-0690-0510 VIAL in 1 BOX > 5 mL in 1 VIAL
0407-0690-1010 VIAL in 1 BOX > 10 mL in 1 VIAL
0407-0690-1210 SYRINGE, PLASTIC in 1 BOX > 10 mL in 1 SYRINGE, PLASTIC
0407-0690-1510 VIAL in 1 BOX > 15 mL in 1 VIAL
0407-0690-1710 SYRINGE, PLASTIC in 1 BOX > 15 mL in 1 SYRINGE, PLASTIC
0407-0690-2010 VIAL in 1 BOX > 20 mL in 1 VIAL
0407-0690-2210 SYRINGE, PLASTIC in 1 BOX > 20 mL in 1 SYRINGE, PLASTIC
0407-0690-3010 VIAL in 1 BOX > 10 mL in 1 VIAL
0407-0690-7010 BOTTLE, PLASTIC in 1 BOX > 100 mL in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.