FDA.reportPublic FDA data

OMNIPAQUE

Product NDC
0407-1412
11-digit product format
004071412
Labeler code
0407
Product ID
0407-1412_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
240 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
IOHEXOL240 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
0407-1412-10OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-10OMNIPAQUE10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1019
0407-1412-20OMNIPAQUE20 mL in 1 VIAL, GLASSINJECTION, SOLUTION2019
0407-1412-20OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-27OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-27OMNIPAQUE150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15019
0407-1412-28OMNIPAQUE200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20019
0407-1412-28OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-29OMNIPAQUE50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5019
0407-1412-29OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-30OMNIPAQUE50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5019
0407-1412-30OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-33OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-33OMNIPAQUE100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10019
0407-1412-34OMNIPAQUE150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15019
0407-1412-34OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-35OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-35OMNIPAQUE200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20019
0407-1412-49OMNIPAQUE150 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION15019
0407-1412-49OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-50OMNIPAQUE50 mL in 1 VIAL, GLASSINJECTION, SOLUTION5019
0407-1412-50OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1412-60OMNIPAQUE100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10019
0407-1412-60OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-1412-10ML - Milliliter0407-14129c7e31e0-0274-47bf-bce9-15821a17546712012-07-24
0407-1412-20ML - Milliliter0407-14126fba4746-aecd-4387-8891-3c561b4a726612012-07-24
0407-1412-28ML - Milliliter0407-1412ae205e3e-9937-452a-8cd4-cf290b524ab012013-07-02
0407-1412-29ML - Milliliter0407-1412730c3a8e-839b-47ec-99fa-4830522ad09312013-07-02
0407-1412-30ML - Milliliter0407-141221062e0b-f913-4943-b89e-1f15f0dfea3d12012-07-24
0407-1412-33ML - Milliliter0407-14124906e957-5ee0-459c-b05b-9e07d261707f12012-07-24
0407-1412-34ML - Milliliter0407-1412493206f8-ca5c-4927-8ab5-1e3603e850cc12012-07-24
0407-1412-35ML - Milliliter0407-14125a78b540-7f75-4661-a1b2-05ca935f268412012-07-24
0407-1412-38ML - Milliliter0407-14129f241bfd-d6ff-40e4-9533-903043061e2812012-07-24
0407-1412-50ML - Milliliter0407-141235de4ede-62de-4f2b-a0b4-14a8fcce12f712012-07-24
0407-1412-60ML - Milliliter0407-141261163694-6f82-4dba-9104-16c9b5722bc312012-07-24

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
0407-1412OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.]18Current NDC, Legacy NDC, 24 package rows20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.zip
0407-1412BL-CONTRAST (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IOHEXOL, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]2Current NDC, Legacy NDC20240802_d498c395-dd95-4796-9030-ce95a9d985b8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0407-1412-100040714121010 VIAL, GLASS in 1 BOX (0407-1412-10) / 10 mL in 1 VIAL, GLASS1985-12-260000-00-00NoNoCurrent
0407-1412-200040714122010 VIAL, GLASS in 1 BOX (0407-1412-20) / 20 mL in 1 VIAL, GLASS1985-12-260000-00-00NoNoCurrent
0407-1412-270040714122710 in 1 BOXHistorical
0407-1412-2800407141228200 mL in 1 BOTTLE, PLASTIC200 mlHistorical
0407-1412-290040714122950 mL in 1 BOTTLE, PLASTIC50 mlHistorical
0407-1412-300040714123010 BOTTLE, PLASTIC in 1 BOX (0407-1412-30) / 50 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1412-330040714123310 BOTTLE, PLASTIC in 1 BOX (0407-1412-33) / 100 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1412-340040714123410 BOTTLE, PLASTIC in 1 BOX (0407-1412-34) > 150 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1412-350040714123510 BOTTLE, PLASTIC in 1 BOX (0407-1412-35) > 200 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1412-380040714123810 BOTTLE, PLASTIC in 1 BOX (0407-1412-38) > 50 mL in 1 BOTTLE, PLASTIC2005-08-110000-00-00NoNoCurrent
0407-1412-390040714123910 BOTTLE, PLASTIC in 1 BOX (0407-1412-39) > 100 mL in 1 BOTTLE, PLASTIC2005-08-110000-00-00NoNoCurrent
0407-1412-400040714124010 BOTTLE, PLASTIC in 1 BOX (0407-1412-40) > 150 mL in 1 BOTTLE, PLASTIC2005-08-110000-00-00NoNoCurrent
0407-1412-4900407141249150 mL in 1 BOTTLE, GLASS150 mlHistorical
0407-1412-500040714125050 mL in 1 VIAL, GLASS50 mlHistorical
0407-1412-6000407141260100 mL in 1 BOTTLE, GLASS100 mlHistorical
0407-1412-840040714128410 BOTTLE in 1 BOX (0407-1412-84) > 100 mL in 1 BOTTLE10 bottle2005-08-110000-00-00NoNoCurrent