FDA.reportPublic FDA data

OMNIPAQUE

Product NDC
0407-1413
11-digit product format
004071413
Labeler code
0407
Product ID
0407-1413_61f3e388-89bf-43d6-ad51-b620fff561fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iohexol
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL
Labeler
GE Healthcare Inc.
Application
NDA018956
Marketing category
NDA
Marketing start
1985-12-26
Substance
IOHEXOL
Active strength
300 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
IOHEXOL300 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
0407-1413-10OMNIPAQUE10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1019
0407-1413-10OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-11OMNIPAQUE10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1019
0407-1413-11OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-30OMNIPAQUE30 mL in 1 VIAL, GLASSINJECTION, SOLUTION3019
0407-1413-30OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-50OMNIPAQUE50 mL in 1 VIAL, GLASSINJECTION, SOLUTION5019
0407-1413-50OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-51OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-51OMNIPAQUE50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5019
0407-1413-53OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-53OMNIPAQUE125 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION12519
0407-1413-59OMNIPAQUE30 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION3019
0407-1413-59OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-60OMNIPAQUE100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10019
0407-1413-60OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-61OMNIPAQUE50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5019
0407-1413-61OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-62OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-62OMNIPAQUE75 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION7519
0407-1413-63OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-63OMNIPAQUE100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10019
0407-1413-65OMNIPAQUE150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15019
0407-1413-65OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-66OMNIPAQUE200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20019
0407-1413-66OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-69OMNIPAQUE125 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION12519
0407-1413-69OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-90OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-90OMNIPAQUE150 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION15019
0407-1413-91OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-91OMNIPAQUE100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10019
0407-1413-92OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-92OMNIPAQUE150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15019
0407-1413-93OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-93OMNIPAQUE200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20019
0407-1413-95OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-95OMNIPAQUE50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5019
0407-1413-96OMNIPAQUE100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10019
0407-1413-96OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-98OMNIPAQUE50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5019
0407-1413-98OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-99OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-99OMNIPAQUE75 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION7519
0407-1413-72Omnipaque500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION50013
0407-1413-72Omnipaque10 in 1 BOXINJECTION, SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-1413-10ML - Milliliter0407-1413f6c83663-10b2-42cf-ba83-919bcfb8575a12012-07-24
0407-1413-25ML - Milliliter0407-14139472d196-2be1-4f38-82a1-52d9ae19a50b12013-02-11
0407-1413-30ML - Milliliter0407-14132c267037-b04e-48f3-b582-91d131c571d312012-07-24
0407-1413-41ML - Milliliter0407-1413bbff2ad6-1006-4b74-9487-0e9c70bd569612012-07-24
0407-1413-42ML - Milliliter0407-1413754fe95a-b92f-4f30-8733-ddaa1df19f5712012-07-24
0407-1413-43ML - Milliliter0407-141302470181-9d8b-4b82-a7a5-91a34a54b29512012-07-24
0407-1413-46ML - Milliliter0407-14138f8cf9e8-d727-4142-bcbf-3fdeb213ec9f12012-07-24
0407-1413-47ML - Milliliter0407-141380e65a85-1227-452e-9b41-6add22a9178d12012-07-24
0407-1413-48ML - Milliliter0407-1413ea845e61-aa73-4083-91b4-257223a7894412017-07-07
0407-1413-50ML - Milliliter0407-14136edc5742-30a3-4cef-a21f-903609c2c58d12012-07-24
0407-1413-51ML - Milliliter0407-14133839e2b1-96b7-4464-9b94-37b55138719312012-07-24
0407-1413-53ML - Milliliter0407-141328d83e77-7fec-4c4b-9dbf-e0556acd104012012-07-24
0407-1413-59ML - Milliliter0407-141320d87029-98d0-49e3-97d8-80f255d7354312012-07-24
0407-1413-60ML - Milliliter0407-14137d7b9373-51ef-45b6-b2e5-56db2feb3f4412012-07-24
0407-1413-61ML - Milliliter0407-14136e43222e-60e5-4401-86f3-1e320f019cf512012-07-24
0407-1413-62ML - Milliliter0407-1413324a54b8-5bb1-4e8f-9c6f-aadba9041c6312012-07-24
0407-1413-63ML - Milliliter0407-1413d46dc144-70fb-4b35-b142-d369cdc5dfd112012-07-24
0407-1413-65ML - Milliliter0407-1413bcf1b44c-835a-4165-8a6e-5a5d501334b912012-07-24
0407-1413-66ML - Milliliter0407-14135c118ca6-aadb-40d5-9bef-4ff28c7040d712012-07-24
0407-1413-68ML - Milliliter0407-141379d8c92d-77f1-473c-81a7-733ab192ea5012013-02-13
0407-1413-69ML - Milliliter0407-1413cd1fc263-9cec-4e85-8083-3bf4fd9d23c012021-07-15
0407-1413-72ML - Milliliter0407-14139a50546e-cf70-42ec-a193-4edc9e82f9b412017-03-06
0407-1413-74ML - Milliliter0407-1413e8eb06be-9c29-4034-b7ae-baa935e2d1e112013-02-11
0407-1413-75ML - Milliliter0407-1413258bca6c-dd38-4f1b-82ee-a8a85f5f971212013-02-11
0407-1413-76ML - Milliliter0407-14136cc76b20-eb45-43a8-b2ff-0d0e6c451f6d12013-02-11
0407-1413-86ML - Milliliter0407-14133786bb7f-fd53-4fc9-8df5-9f6e734281c812012-07-24
0407-1413-87ML - Milliliter0407-1413dd082764-64b6-4dbc-b63a-99793887cce012012-07-24
0407-1413-88ML - Milliliter0407-14137e487cb4-f19d-43dc-93ee-988285a1840e12012-07-24
0407-1413-89ML - Milliliter0407-141359a2685c-f6b7-43b9-bc2b-b479e4f7f5b112014-10-03
0407-1413-90ML - Milliliter0407-141336f37e6f-3666-47b5-8ce4-94ab7425fa4b12012-07-24
0407-1413-92ML - Milliliter0407-1413b240bf47-042a-4ed8-b1f4-52cfea7c3e0112013-07-02
0407-1413-98ML - Milliliter0407-14138fe2132b-7de2-4488-af55-2f74e896756412013-07-02

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
0407-1413OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.]18Current NDC, Legacy NDC, 44 package rows20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.zip
0407-1413OMNIPAQUE (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
0407-1413-100040714131010 VIAL, GLASS in 1 BOX (0407-1413-10) / 10 mL in 1 VIAL, GLASS1985-12-260000-00-00NoNoCurrent
0407-1413-110040714131110 mL in 1 VIAL, GLASS10 mlHistorical
0407-1413-300040714133030 mL in 1 VIAL, GLASS30 mlHistorical
0407-1413-410040714134110 VIAL in 1 BOX (0407-1413-41) > 50 mL in 1 VIAL10 vial2006-09-210000-00-00NoNoCurrent
0407-1413-420040714134210 BOTTLE in 1 BOX (0407-1413-42) > 50 mL in 1 BOTTLE10 bottle2006-09-210000-00-00NoNoCurrent
0407-1413-430040714134310 BOTTLE in 1 BOX (0407-1413-43) > 100 mL in 1 BOTTLE10 bottle2006-09-210000-00-00NoNoCurrent
0407-1413-460040714134610 BOTTLE in 1 BOX (0407-1413-46) > 150 mL in 1 BOTTLE10 bottle2006-09-210000-00-00NoNoCurrent
0407-1413-470040714134710 BOTTLE in 1 BOX (0407-1413-47) > 125 mL in 1 BOTTLE10 bottle2006-09-210000-00-00NoNoCurrent
0407-1413-480040714134810 BOTTLE, PLASTIC in 1 BOX (0407-1413-48) > 500 mL in 1 BOTTLE, PLASTIC2016-12-210000-00-00NoNoCurrent
0407-1413-500040714135050 mL in 1 VIAL, GLASS50 mlHistorical
0407-1413-510040714135110 in 1 BOXHistorical
0407-1413-530040714135310 BOTTLE, GLASS in 1 BOX (0407-1413-53) / 125 mL in 1 BOTTLE, GLASS1985-12-260000-00-00NoNoCurrent
0407-1413-590040714135910 BOTTLE, PLASTIC in 1 BOX (0407-1413-59) / 30 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-6000407141360100 mL in 1 BOTTLE, GLASS100 mlHistorical
0407-1413-610040714136110 BOTTLE, PLASTIC in 1 BOX (0407-1413-61) / 50 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-620040714136210 BOTTLE, PLASTIC in 1 BOX (0407-1413-62) > 75 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-630040714136310 BOTTLE, PLASTIC in 1 BOX (0407-1413-63) / 100 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-650040714136510 BOTTLE, PLASTIC in 1 BOX (0407-1413-65) / 150 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-660040714136610 BOTTLE, PLASTIC in 1 BOX (0407-1413-66) > 200 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-680040714136810 BOTTLE, PLASTIC in 1 BOX (0407-1413-68) > 500 mL in 1 BOTTLE, PLASTIC2004-09-030000-00-00NoNoCurrent
0407-1413-690040714136910 BOTTLE, PLASTIC in 1 BOX (0407-1413-69) > 125 mL in 1 BOTTLE, PLASTIC2020-03-230000-00-00NoNoCurrent
0407-1413-720040714137210 BOTTLE, PLASTIC in 1 BOX (0407-1413-72) / 500 mL in 1 BOTTLE, PLASTIC2016-12-210000-00-00NoNoCurrent
0407-1413-860040714138610 BOTTLE, PLASTIC in 1 BOX (0407-1413-86) > 50 mL in 1 BOTTLE, PLASTIC2006-09-210000-00-00NoNoCurrent
0407-1413-870040714138710 BOTTLE, PLASTIC in 1 BOX (0407-1413-87) > 100 mL in 1 BOTTLE, PLASTIC2006-09-210000-00-00NoNoCurrent
0407-1413-880040714138810 BOTTLE, PLASTIC in 1 BOX (0407-1413-88) > 150 mL in 1 BOTTLE, PLASTIC2006-09-210000-00-00NoNoCurrent
0407-1413-890040714138910 BOTTLE, PLASTIC in 1 BOX (0407-1413-89) > 500 mL in 1 BOTTLE, PLASTIC2005-08-032024-10-22NoNoCurrent
0407-1413-900040714139010 in 1 BOXHistorical
0407-1413-910040714139110 in 1 BOXHistorical
0407-1413-920040714139210 in 1 BOXHistorical
0407-1413-930040714139310 in 1 BOXHistorical
0407-1413-950040714139510 in 1 BOXHistorical
0407-1413-9600407141396100 mL in 1 BOTTLE, GLASS100 mlHistorical
0407-1413-980040714139850 mL in 1 BOTTLE, PLASTIC50 mlHistorical
0407-1413-990040714139910 in 1 BOXHistorical