0407-2223 NDC - VISIPAQUE ()

Drug Information

Product NDC: 0407-2223
Proprietary Name: Visipaque
Non Proprietary Name:
Active Ingredient(s): 320 mg/mL IODIXANOL320 mg/mL IODIXANOL
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:	GE Healthcare Inc.
Product Type:
FDA Application Number:	NDA020808
Marketing Category:	NDA
Start Marketing Date:	6/1/2010
End Marketing Date:	11/9/2024

Package Information

No.	Package Code	Package Description	Billing Unit
1	0407-2223-01	10 VIAL in 1 BOX (0407-2223-01) / 50 mL in 1 VIAL	ML
2	0407-2223-02	10 BOTTLE, GLASS in 1 BOX (0407-2223-02) / 100 mL in 1 BOTTLE, GLASS	ML
3	0407-2223-03	10 BOTTLE, GLASS in 1 BOX (0407-2223-03) / 150 mL in 1 BOTTLE, GLASS	ML
4	0407-2223-04	10 BOTTLE, GLASS in 1 BOX (0407-2223-04) / 200 mL in 1 BOTTLE, GLASS	ML
5	0407-2223-06	10 BOTTLE, GLASS in 1 BOX (0407-2223-06) / 50 mL in 1 BOTTLE, GLASS	ML
6	0407-2223-16	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-16) / 50 mL in 1 BOTTLE, PLASTIC	ML
7	0407-2223-17	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-17) / 100 mL in 1 BOTTLE, PLASTIC	ML
8	0407-2223-19	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-19) / 150 mL in 1 BOTTLE, PLASTIC	ML
9	0407-2223-21	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-21) / 200 mL in 1 BOTTLE, PLASTIC	ML
10	0407-2223-23	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-23) / 500 mL in 1 BOTTLE, PLASTIC	ML
11	0407-2223-50	10 BOTTLE, GLASS in 1 BOX (0407-2223-50) / 50 mL in 1 BOTTLE, GLASS
12	0407-2223-51	10 BOTTLE, GLASS in 1 BOX (0407-2223-51) / 100 mL in 1 BOTTLE, GLASS
13	0407-2223-53	10 BOTTLE, GLASS in 1 BOX (0407-2223-53) / 200 mL in 1 BOTTLE, GLASS
14	0407-2223-54	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-54) / 50 mL in 1 BOTTLE, PLASTIC
15	0407-2223-55	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-55) / 100 mL in 1 BOTTLE, PLASTIC	ML
16	0407-2223-56	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-56) / 150 mL in 1 BOTTLE, PLASTIC
17	0407-2223-57	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-57) / 200 mL in 1 BOTTLE, PLASTIC
18	0407-2223-58	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-58) / 500 mL in 1 BOTTLE, PLASTIC
19	0407-2223-60	10 VIAL, GLASS in 1 BOX (0407-2223-60) / 50 mL in 1 VIAL, GLASS	ML
20	0407-2223-61	10 BOTTLE, GLASS in 1 BOX (0407-2223-61) / 50 mL in 1 BOTTLE, GLASS	ML
21	0407-2223-62	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-62) / 50 mL in 1 BOTTLE, PLASTIC	ML
22	0407-2223-63	10 BOTTLE, GLASS in 1 BOX (0407-2223-63) / 100 mL in 1 BOTTLE, GLASS	ML
23	0407-2223-64	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-64) / 100 mL in 1 BOTTLE, PLASTIC	ML
24	0407-2223-65	10 BOTTLE, GLASS in 1 BOX (0407-2223-65) / 150 mL in 1 BOTTLE, GLASS	ML
25	0407-2223-66	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-66) / 150 mL in 1 BOTTLE, PLASTIC	ML
26	0407-2223-67	10 BOTTLE, PLASTIC in 1 BOX (0407-2223-67) / 200 mL in 1 BOTTLE, PLASTIC	ML

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0407-2223	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	Visipaque	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	NDA020808	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	0407-2223	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	Visipaque	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	5/1/2006	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	NDA020808	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	0407-2223	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	Visipaque	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	9/9/2003	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	NDA020351	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.

0407-2223 NDC - VISIPAQUE ()

Drug Information

Labeler Information

Package Information

NDC Record

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