0407-0690 NDC - OMNISCAN ()

Drug Information

Product NDC: 0407-0690
Proprietary Name: OMNISCAN
Non Proprietary Name:
Active Ingredient(s): 287 mg/mL GADODIAMIDE
Administration Route(s):
Dosage Form(s):
Pharmacy Class(es): Magnetic Resonance Contrast Activity [MoA]; Paramagnetic Contrast Agent [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	GE Healthcare Inc.
Product Type:
FDA Application Number:	NDA022066
Marketing Category:	NDA
Start Marketing Date:	10/2/2007
End Marketing Date:	1/17/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	0407-0690-05	10 VIAL in 1 BOX (0407-0690-05) / 5 mL in 1 VIAL	ML
2	0407-0690-10	10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL	ML
3	0407-0690-12	10 SYRINGE, PLASTIC in 1 BOX (0407-0690-12) / 10 mL in 1 SYRINGE, PLASTIC	ML
4	0407-0690-15	10 VIAL in 1 BOX (0407-0690-15) / 15 mL in 1 VIAL	ML
5	0407-0690-17	10 SYRINGE, PLASTIC in 1 BOX (0407-0690-17) / 15 mL in 1 SYRINGE, PLASTIC	ML
6	0407-0690-20	10 VIAL in 1 BOX (0407-0690-20) / 20 mL in 1 VIAL	ML
7	0407-0690-22	10 SYRINGE, PLASTIC in 1 BOX (0407-0690-22) / 20 mL in 1 SYRINGE, PLASTIC	ML
8	0407-0690-30	10 VIAL in 1 BOX (0407-0690-30) / 10 mL in 1 VIAL	ML
9	0407-0690-40	10 VIAL in 1 BOX (0407-0690-40) / 15 mL in 1 VIAL	ML
10	0407-0690-42	10 SYRINGE in 1 BOX (0407-0690-42) / 15 mL in 1 SYRINGE	ML
11	0407-0690-43	10 SYRINGE in 1 BOX (0407-0690-43) / 20 mL in 1 SYRINGE	ML
12	0407-0690-50	10 VIAL in 1 BOX (0407-0690-50) / 20 mL in 1 VIAL	ML
13	0407-0690-70	10 BOTTLE, PLASTIC in 1 BOX (0407-0690-70) / 100 mL in 1 BOTTLE, PLASTIC	ML

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0407-0690	The 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 NAME	OMNISCAN	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	6/1/2010	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	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.
APPLICATION NUMBER	NDA020123	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.
LABELER NAME	GE Healthcare Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC	0407-0690	The 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 NAME	OMNISCAN	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	10/2/2007	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	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.
APPLICATION NUMBER	NDA022066	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.
LABELER NAME	GE Healthcare Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC	0407-0690	The 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 NAME	OMNISCAN	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	4/19/2002	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	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.
APPLICATION NUMBER	NDA020123	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.
LABELER NAME	GE Healthcare Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/26/2025

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