FDA.reportPublic FDA data

OMNIPAQUE

Product NDC
0407-1414
11-digit product format
004071414
Labeler code
0407
Product ID
0407-1414_61f3e388-89bf-43d6-ad51-b620fff561fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iohexol
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRAVASCULAR; INTRAVENOUS; ORAL
Labeler
GE Healthcare Inc.
Application
NDA018956
Marketing category
NDA
Marketing start
1985-12-26
Substance
IOHEXOL
Active strength
350 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
IOHEXOL350 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
0407-1414-03OMNIPAQUE150 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION15019
0407-1414-03OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-04OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-04OMNIPAQUE200 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION20019
0407-1414-20OMNIPAQUE75 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION7519
0407-1414-20OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-21OMNIPAQUE50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5019
0407-1414-21OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-22OMNIPAQUE100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10019
0407-1414-22OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-23OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-23OMNIPAQUE150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15019
0407-1414-24OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-24OMNIPAQUE200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20019
0407-1414-50OMNIPAQUE50 mL in 1 VIAL, GLASSINJECTION, SOLUTION5019
0407-1414-50OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-51OMNIPAQUE50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5019
0407-1414-51OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-52OMNIPAQUE50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5019
0407-1414-52OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-53OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-53OMNIPAQUE100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10019
0407-1414-60OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-60OMNIPAQUE100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10019
0407-1414-76OMNIPAQUE125 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION12519
0407-1414-76OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-80OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-80OMNIPAQUE250 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION25019
0407-1414-89OMNIPAQUE50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5019
0407-1414-89OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-90OMNIPAQUE75 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION7519
0407-1414-90OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-91OMNIPAQUE100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10019
0407-1414-91OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-93OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-93OMNIPAQUE150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15019
0407-1414-94OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-94OMNIPAQUE200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20019
0407-1414-95OMNIPAQUE125 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION12519
0407-1414-95OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1414-72Omnipaque500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION50013
0407-1414-72Omnipaque10 in 1 BOXINJECTION, SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-1414-03ML - Milliliter0407-1414bea144d9-8f56-4a19-9a68-fbae0a3f694712012-07-24
0407-1414-04ML - Milliliter0407-14147fdd0ef5-762f-49ec-8ba2-ceab5669e01d12013-02-13
0407-1414-36ML - Milliliter0407-141420efe7db-fdc2-4cb7-975c-f3c0612d9c9112013-02-11
0407-1414-41ML - Milliliter0407-1414d90f3d62-7061-4308-a23e-c62fec78fa8212012-07-24
0407-1414-44ML - Milliliter0407-14146d45f639-c20a-44ac-8218-5549900bd5f412012-07-24
0407-1414-45ML - Milliliter0407-14144fb4ca54-d115-457d-90c5-f0b7930a3d9812012-07-24
0407-1414-48ML - Milliliter0407-1414dcaad1b3-1651-4f6c-9d85-df2c73ce526812017-07-07
0407-1414-50ML - Milliliter0407-141480d315ca-7035-4aab-a8f2-07314c40f33912012-07-24
0407-1414-51ML - Milliliter0407-1414fa4beebd-4311-4da9-9c34-62e47cf4cab112012-07-24
0407-1414-60ML - Milliliter0407-141414dce833-e2c3-4734-a3c7-d844a53abe9512012-07-24
0407-1414-72ML - Milliliter0407-1414ae628c77-ab0b-4492-9f08-898999ad027b12017-03-06
0407-1414-76ML - Milliliter0407-14147d22aa66-ccc9-4126-b6a9-950eb5190d3f12012-07-24
0407-1414-82ML - Milliliter0407-14140e5f7463-2c86-427b-aac2-bc8ad9e4a60612012-07-24
0407-1414-83ML - Milliliter0407-1414b61f8c6c-3793-4b6a-a10c-890e48c155eb12022-06-06
0407-1414-84ML - Milliliter0407-1414b51f5b27-9e2b-4279-b153-61a1707fbc0412012-07-24
0407-1414-85ML - Milliliter0407-1414a8eba62a-5cf1-4474-8217-ef78ef8631b912012-07-24
0407-1414-86ML - Milliliter0407-14140ef5b96a-7c46-49ca-879d-0d08efffb21012012-07-24
0407-1414-87ML - Milliliter0407-141467e3f00e-f22c-42ff-9934-e6f5e5bc8bba12012-07-24
0407-1414-88ML - Milliliter0407-1414ebede9e1-6ac6-43c2-9cca-ca17d402082f12014-10-03
0407-1414-89ML - Milliliter0407-14145e132ad4-fa32-4759-ac13-3477af81731112012-07-24
0407-1414-90ML - Milliliter0407-1414d421e421-88ee-46b4-b4fc-e5327676934512012-07-24
0407-1414-91ML - Milliliter0407-14141ba21b66-8d58-49a3-8eb9-7235f977933212012-07-24
0407-1414-93ML - Milliliter0407-1414d568274d-2dd0-4681-a195-9c69692205f312012-07-24
0407-1414-94ML - Milliliter0407-1414e760fd69-71d9-4133-89ab-c5412e861e0412012-07-24
0407-1414-95ML - Milliliter0407-1414e08b8138-5d25-46df-82e0-9a012a376fa312021-07-15
0407-1414-98ML - Milliliter0407-1414741165a1-4b2a-4625-b7f1-0722bec949b312013-02-13

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
0407-1414OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.]18Current NDC, Legacy NDC, 40 package rows20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.zip
0407-1414OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE]11Current NDC, Legacy NDC, 2 package rows20241020_164b27b9-97ae-4279-896f-1c4afa583dd1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0407-1414-0300407141403150 mL in 1 BOTTLE, GLASS150 mlHistorical
0407-1414-040040714140410 in 1 BOXHistorical
0407-1414-200040714142075 mL in 1 BOTTLE, PLASTIC75 mlHistorical
0407-1414-210040714142150 mL in 1 BOTTLE, PLASTIC50 mlHistorical
0407-1414-2200407141422100 mL in 1 BOTTLE, PLASTIC100 mlHistorical
0407-1414-230040714142310 in 1 BOXHistorical
0407-1414-240040714142410 in 1 BOXHistorical
0407-1414-410040714144110 BOTTLE in 1 BOX (0407-1414-41) > 150 mL in 1 BOTTLE10 bottle2006-07-210000-00-00NoNoCurrent
0407-1414-420040714144210 BOTTLE in 1 BOX (0407-1414-42) > 200 mL in 1 BOTTLE10 bottle2006-07-210000-00-00NoNoCurrent
0407-1414-430040714144310 VIAL in 1 BOX (0407-1414-43) > 50 mL in 1 VIAL10 vial2006-07-210000-00-00NoNoCurrent
0407-1414-440040714144410 BOTTLE in 1 BOX (0407-1414-44) > 50 mL in 1 BOTTLE10 bottle2006-07-210000-00-00NoNoCurrent
0407-1414-450040714144510 BOTTLE in 1 BOX (0407-1414-45) > 100 mL in 1 BOTTLE10 bottle2006-07-210000-00-00NoNoCurrent
0407-1414-480040714144810 BOTTLE, PLASTIC in 1 BOX (0407-1414-48) > 500 mL in 1 BOTTLE, PLASTIC2016-12-210000-00-00NoNoCurrent
0407-1414-500040714145050 mL in 1 VIAL, GLASS50 mlHistorical
0407-1414-510040714145150 mL in 1 BOTTLE, GLASS50 mlHistorical
0407-1414-520040714145250 mL in 1 BOTTLE, GLASS50 mlHistorical
0407-1414-530040714145310 in 1 BOXHistorical
0407-1414-600040714146010 in 1 BOXHistorical
0407-1414-720040714147210 BOTTLE, PLASTIC in 1 BOX (0407-1414-72) / 500 mL in 1 BOTTLE, PLASTIC2016-12-210000-00-00NoNoCurrent
0407-1414-760040714147610 BOTTLE, GLASS in 1 BOX (0407-1414-76) / 125 mL in 1 BOTTLE, GLASS1985-12-260000-00-00NoNoCurrent
0407-1414-800040714148010 in 1 BOXHistorical
0407-1414-820040714148210 BOTTLE, PLASTIC in 1 BOX (0407-1414-82) > 50 mL in 1 BOTTLE, PLASTIC2006-07-210000-00-00NoNoCurrent
0407-1414-830040714148310 BOTTLE in 1 BOX (0407-1414-83) > 125 mL in 1 BOTTLE10 bottle2020-03-232024-06-19NoNoCurrent
0407-1414-840040714148410 BOTTLE, PLASTIC in 1 BOX (0407-1414-84) > 100 mL in 1 BOTTLE, PLASTIC2006-07-212024-11-07NoNoCurrent
0407-1414-850040714148510 BOTTLE in 1 BOX (0407-1414-85) > 125 mL in 1 BOTTLE10 bottle2006-07-210000-00-00NoNoCurrent
0407-1414-860040714148610 BOTTLE, PLASTIC in 1 BOX (0407-1414-86) > 150 mL in 1 BOTTLE, PLASTIC2006-07-210000-00-00NoNoCurrent
0407-1414-870040714148710 BOTTLE, PLASTIC in 1 BOX (0407-1414-87) > 200 mL in 1 BOTTLE, PLASTIC2006-07-210000-00-00NoNoCurrent
0407-1414-880040714148810 BOTTLE, PLASTIC in 1 BOX (0407-1414-88) > 500 mL in 1 BOTTLE, PLASTIC2005-08-032024-11-08NoNoCurrent
0407-1414-890040714148910 BOTTLE, PLASTIC in 1 BOX (0407-1414-89) / 50 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1414-900040714149010 BOTTLE, PLASTIC in 1 BOX (0407-1414-90) / 75 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1414-910040714149110 BOTTLE, PLASTIC in 1 BOX (0407-1414-91) / 100 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1414-930040714149310 BOTTLE, PLASTIC in 1 BOX (0407-1414-93) / 150 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1414-940040714149410 BOTTLE, PLASTIC in 1 BOX (0407-1414-94) / 200 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1414-950040714149510 BOTTLE, PLASTIC in 1 BOX (0407-1414-95) > 125 mL in 1 BOTTLE, PLASTIC2020-03-230000-00-00NoNoCurrent
0407-1414-980040714149810 BOTTLE, PLASTIC in 1 BOX (0407-1414-98) > 500 mL in 1 BOTTLE, PLASTIC2004-09-030000-00-00NoNoCurrent