FDA.reportPublic FDA data

Visipaque

Product NDC
0407-2222
11-digit product format
004072222
Labeler code
0407
Product ID
0407-2222_3bf8b69f-3b64-4112-b08a-53bbf6dd57e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iodixanol
Dosage form
INJECTION, SOLUTION
Route
INTRAVASCULAR
Labeler
GE Healthcare Inc.
Application
NDA020351
Marketing category
NDA
Marketing start
2002-12-13
Substance
IODIXANOL
Active strength
270 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Visipaque
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IODIXANOL270 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHW8W27HTXX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0407-2222-01Visipaque50 mL in 1 VIALINJECTION, SOLUTION5014
0407-2222-01Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-02Visipaque100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10014
0407-2222-02Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-03Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-03Visipaque150 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION15014
0407-2222-06Visipaque50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5014
0407-2222-06Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-16Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-16Visipaque50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5014
0407-2222-17Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-17Visipaque100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10014
0407-2222-19Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-19Visipaque150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15014
0407-2222-21Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-21Visipaque200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20014
0407-2222-50Visipaque100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10014
0407-2222-50Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-52Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-52Visipaque50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5014
0407-2222-53Visipaque100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10014
0407-2222-53Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-54Visipaque150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15014
0407-2222-54Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-55Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2222-55Visipaque200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-2222-01ML - Milliliter0407-22223979ea4a-28a2-47e0-b0bf-6cc3013a419412012-07-24
0407-2222-02ML - Milliliter0407-2222dd631420-f7f0-4d9a-a9f9-cb37e40af19112012-07-24
0407-2222-03ML - Milliliter0407-22220c0c7593-b14a-4ff4-a7d5-54bf4249175412012-07-24
0407-2222-16ML - Milliliter0407-222274bf3a23-ac37-44ee-ba2f-0bf344b58a6d12012-07-24
0407-2222-17ML - Milliliter0407-222256700add-789b-44d8-9ae2-a2de9d4df07312012-07-24
0407-2222-19ML - Milliliter0407-222282dab9b6-9326-4b80-a41a-517e53eddc9b12012-07-24
0407-2222-21ML - Milliliter0407-2222b6dd0fca-1d7f-43be-a9e9-21d0f7e161ec12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IodixanolACTIVE INGREDIENTHW8W27HTXXVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
IodixanolACTIVE MOIETYHW8W27HTXXVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5MVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
Edetate Calcium DisodiumINACTIVE INGREDIENT25IH6R4SGFVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
TromethamineINACTIVE INGREDIENT023C2WHX2VVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
IodixanolACTIVE INGREDIENTHW8W27HTXXVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]4
IodixanolACTIVE MOIETYHW8W27HTXXVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]4
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]4
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]4
hydrochloric acidINACTIVE INGREDIENTQTT17582CBVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]4
sodium chlorideINACTIVE INGREDIENT451W47IQ8XVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]4
tromethamineINACTIVE INGREDIENT023C2WHX2VVISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0407-2222VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]15Current NDC, Legacy NDC20230515_2d964c13-88ad-43be-88d4-a3a7ea4d5b5e.zip
0407-2222VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]13Current NDC, Legacy NDC, 26 package rows20230506_e9d87b8c-7695-4c0f-8e81-000dedb5f66d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0407-2222-010040722220150 mL in 1 VIAL50 mlHistorical
0407-2222-0200407222202100 mL in 1 BOTTLE, GLASS100 mlHistorical
0407-2222-030040722220310 in 1 BOXHistorical
0407-2222-060040722220650 mL in 1 BOTTLE, GLASS50 mlHistorical
0407-2222-160040722221610 BOTTLE, PLASTIC in 1 BOX (0407-2222-16) / 50 mL in 1 BOTTLE, PLASTIC2002-12-130000-00-00NoNoCurrent
0407-2222-170040722221710 BOTTLE, PLASTIC in 1 BOX (0407-2222-17) / 100 mL in 1 BOTTLE, PLASTIC2002-12-130000-00-00NoNoCurrent
0407-2222-190040722221910 BOTTLE, PLASTIC in 1 BOX (0407-2222-19) / 150 mL in 1 BOTTLE, PLASTIC2002-12-130000-00-00NoNoCurrent
0407-2222-210040722222110 BOTTLE, PLASTIC in 1 BOX (0407-2222-21) / 200 mL in 1 BOTTLE, PLASTIC2002-12-130000-00-00NoNoCurrent
0407-2222-5000407222250100 mL in 1 BOTTLE, GLASS100 mlHistorical
0407-2222-520040722225210 in 1 BOXHistorical
0407-2222-5300407222253100 mL in 1 BOTTLE, PLASTIC100 mlHistorical
0407-2222-5400407222254150 mL in 1 BOTTLE, PLASTIC150 mlHistorical
0407-2222-550040722225510 in 1 BOXHistorical