Omniscan Injection
NDC Package 0407-0690-40

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Omniscan (gadodiamide) injection is oMNISCAN is contraindicated in patients with:Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2) or acute kidney injury Prior hypersensitivity to OMNISCAN. This formulation utilizes a injection delivery system. Marketed by Ge Healthcare Inc., this product is identified by NDC 0407-0690 and is authorized under FDA application NDA020123.

Identification & Billing

NDC Package Code
0407-0690-40
Package Description
10 VIAL in 1 BOX / 15 mL in 1 VIAL
Product Code
0407-0690
11-Digit Billing Format
00407069040
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Omniscan
Non-Proprietary Name
Gadodiamide
Substance Name
Gadodiamide
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GADODIAMIDE 287 mg/mL
Pharmacologic Class
Usage Information
OMNISCAN is contraindicated in patients with:Chronic, severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2) or acute kidney injury Prior hypersensitivity to OMNISCAN

Regulatory & Marketing

Labeler Name
Ge Healthcare Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020123
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-19-2002
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0407-0690). Click a package code to view its specific billing and regulatory data.

0407-0690-05
10 VIAL in 1 BOX / 5 mL in 1 VIAL
0407-0690-10
10 VIAL in 1 BOX / 10 mL in 1 VIAL
0407-0690-12
10 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC
0407-0690-15
10 VIAL in 1 BOX / 15 mL in 1 VIAL
0407-0690-17
10 SYRINGE, PLASTIC in 1 BOX / 15 mL in 1 SYRINGE, PLASTIC
0407-0690-20
10 VIAL in 1 BOX / 20 mL in 1 VIAL
0407-0690-22
10 SYRINGE, PLASTIC in 1 BOX / 20 mL in 1 SYRINGE, PLASTIC
0407-0690-30
10 VIAL in 1 BOX / 10 mL in 1 VIAL
0407-0690-42
10 SYRINGE in 1 BOX / 15 mL in 1 SYRINGE
0407-0690-43
10 SYRINGE in 1 BOX / 20 mL in 1 SYRINGE
0407-0690-50
10 VIAL in 1 BOX / 20 mL in 1 VIAL
0407-0690-70
10 BOTTLE, PLASTIC in 1 BOX / 100 mL in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0407-0690-40 identifies a specific commercial package of 10 vial in 1 box / 15 ml in 1 vial of Omniscan, a human prescription drug labeled by Ge Healthcare Inc.. This injection is formulated for intravenous use and contains gadodiamide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Ge Healthcare Inc. on April 19, 2002. The current certification is valid through December 31, 2026.

How is this Ge Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00407069040. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0407-0690-40
11-Digit CMS (5-4-2)
00407-0690-40

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.