0407-1413 NDC - OMNIPAQUE ()

Drug Information

Product NDC: 0407-1413
Proprietary Name: Omnipaque
Non Proprietary Name:
Active Ingredient(s): 300 mg/mL IOHEXOL300 mg/mL IOHEXOL
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:	NDA020608
Marketing Category:	NDA
Start Marketing Date:	9/3/2004
End Marketing Date:	3/24/2025

Package Information

No.	Package Code	Package Description	Billing Unit
1	0407-1413-10	10 VIAL, GLASS in 1 BOX (0407-1413-10) / 10 mL in 1 VIAL, GLASS	ML
2	0407-1413-11	10 VIAL, GLASS in 1 BOX (0407-1413-11) / 10 mL in 1 VIAL, GLASS
3	0407-1413-30	10 VIAL, GLASS in 1 BOX (0407-1413-30) / 30 mL in 1 VIAL, GLASS	ML
4	0407-1413-41	10 VIAL in 1 BOX (0407-1413-41) / 50 mL in 1 VIAL	ML
5	0407-1413-42	10 BOTTLE in 1 BOX (0407-1413-42) / 50 mL in 1 BOTTLE	ML
6	0407-1413-43	10 BOTTLE in 1 BOX (0407-1413-43) / 100 mL in 1 BOTTLE	ML
7	0407-1413-46	10 BOTTLE in 1 BOX (0407-1413-46) / 150 mL in 1 BOTTLE	ML
8	0407-1413-47	10 BOTTLE in 1 BOX (0407-1413-47) / 125 mL in 1 BOTTLE	ML
9	0407-1413-48	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-48) / 500 mL in 1 BOTTLE, PLASTIC	ML
10	0407-1413-50	10 VIAL, GLASS in 1 BOX (0407-1413-50) / 50 mL in 1 VIAL, GLASS	ML
11	0407-1413-51	10 BOTTLE, GLASS in 1 BOX (0407-1413-51) / 50 mL in 1 BOTTLE, GLASS	ML
12	0407-1413-53	10 BOTTLE, GLASS in 1 BOX (0407-1413-53) / 125 mL in 1 BOTTLE, GLASS	ML
13	0407-1413-59	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-59) / 30 mL in 1 BOTTLE, PLASTIC	ML
14	0407-1413-60	10 BOTTLE, GLASS in 1 BOX (0407-1413-60) / 100 mL in 1 BOTTLE, GLASS	ML
15	0407-1413-61	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-61) / 50 mL in 1 BOTTLE, PLASTIC	ML
16	0407-1413-62	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-62) / 75 mL in 1 BOTTLE, PLASTIC	ML
17	0407-1413-63	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-63) / 100 mL in 1 BOTTLE, PLASTIC	ML
18	0407-1413-65	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-65) / 150 mL in 1 BOTTLE, PLASTIC	ML
19	0407-1413-66	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-66) / 200 mL in 1 BOTTLE, PLASTIC	ML
20	0407-1413-68	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-68) / 500 mL in 1 BOTTLE, PLASTIC	ML
21	0407-1413-69	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-69) / 125 mL in 1 BOTTLE, PLASTIC	ML
22	0407-1413-72	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-72) / 500 mL in 1 BOTTLE, PLASTIC	ML
23	0407-1413-86	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-86) / 50 mL in 1 BOTTLE, PLASTIC	ML
24	0407-1413-87	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-87) / 100 mL in 1 BOTTLE, PLASTIC	ML
25	0407-1413-88	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-88) / 150 mL in 1 BOTTLE, PLASTIC	ML
26	0407-1413-89	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-89) / 500 mL in 1 BOTTLE, PLASTIC	ML
27	0407-1413-90	10 BOTTLE, GLASS in 1 BOX (0407-1413-90) / 150 mL in 1 BOTTLE, GLASS	ML
28	0407-1413-91	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-91) / 100 mL in 1 BOTTLE, PLASTIC
29	0407-1413-92	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-92) / 150 mL in 1 BOTTLE, PLASTIC	ML
30	0407-1413-93	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-93) / 200 mL in 1 BOTTLE, PLASTIC
31	0407-1413-94	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-94) / 500 mL in 1 BOTTLE, PLASTIC
32	0407-1413-95	10 BOTTLE, GLASS in 1 BOX (0407-1413-95) / 50 mL in 1 BOTTLE, GLASS
33	0407-1413-96	10 BOTTLE, GLASS in 1 BOX (0407-1413-96) / 100 mL in 1 BOTTLE, GLASS
34	0407-1413-98	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-98) / 50 mL in 1 BOTTLE, PLASTIC	ML
35	0407-1413-99	10 BOTTLE, PLASTIC in 1 BOX (0407-1413-99) / 75 mL in 1 BOTTLE, PLASTIC

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0407-1413	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	Omnipaque	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	12/21/2016	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	NDA020608	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	Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC	0407-1413	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	OMNIPAQUE	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	9/21/2006	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	NDA020608	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	0407-1413	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	Omnipaque	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	8/3/2005	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	NDA020608	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	0407-1413	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	Omnipaque	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	9/3/2004	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	NDA020608	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	0407-1413	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	OMNIPAQUE	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	12/26/1985	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	NDA018956	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	0407-1413	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	Omnipaque	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	12/21/2016	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	NDA020608	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	Name of Company corresponding to the labeler code segment of the Product NDC.

0407-1413 NDC - OMNIPAQUE ()

Drug Information

Labeler Information

Package Information

NDC Record

Download Record