FDA.reportPublic FDA data

OMNIPAQUE

Product NDC
0407-1411
11-digit product format
004071411
Labeler code
0407
Product ID
0407-1411_61f3e388-89bf-43d6-ad51-b620fff561fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iohexol
Dosage form
INJECTION, SOLUTION
Route
INTRATHECAL; ORAL; RECTAL
Labeler
GE Healthcare Inc.
Application
NDA018956
Marketing category
NDA
Marketing start
2004-07-15
Substance
IOHEXOL
Active strength
180 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OMNIPAQUE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOHEXOL180 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4419T9MX03

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0407-1411-10OMNIPAQUE10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1019
0407-1411-10OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1411-20OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1411-20OMNIPAQUE20 mL in 1 VIAL, GLASSINJECTION, SOLUTION2019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-1411-10ML - Milliliter0407-1411c5f13cb4-736d-4410-a07e-6d8d831e64fc12012-07-24
0407-1411-20ML - Milliliter0407-141126baa7fc-176b-4110-b2b5-64404d1a836a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IohexolACTIVE INGREDIENT4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
IohexolACTIVE MOIETY4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
hydrochloric acidINACTIVE INGREDIENTQTT17582CBOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
sodium hydroxideINACTIVE INGREDIENT55X04QC32IOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
tromethamineINACTIVE INGREDIENT023C2WHX2VOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0407-1411OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.]18Current NDC, Legacy NDC, 4 package rows20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0407-1411-100040714111010 VIAL, GLASS in 1 BOX (0407-1411-10) / 10 mL in 1 VIAL, GLASS2004-07-150000-00-00NoNoCurrent
0407-1411-200040714112010 VIAL, GLASS in 1 BOX (0407-1411-20) > 20 mL in 1 VIAL, GLASS2004-07-150000-00-00NoNoCurrent