FDA.reportPublic FDA data

Visipaque

Product NDC
0407-2223
11-digit product format
004072223
Labeler code
0407
Product ID
0407-2223_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
2003-09-09
Substance
IODIXANOL
Active strength
320 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
IODIXANOL320 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
0407-2223-23Visipaque500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION50017
0407-2223-23Visipaque10 in 1 BOXINJECTION, SOLUTION1017
0407-2223-58Visipaque500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION50017
0407-2223-58Visipaque10 in 1 BOXINJECTION, SOLUTION1017
0407-2223-01Visipaque50 mL in 1 VIALINJECTION, SOLUTION5014
0407-2223-01Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-02Visipaque100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10014
0407-2223-02Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-03Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-03Visipaque150 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION15014
0407-2223-04Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-04Visipaque200 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION20014
0407-2223-06Visipaque50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5014
0407-2223-06Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-16Visipaque50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5014
0407-2223-16Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-17Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-17Visipaque100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10014
0407-2223-19Visipaque150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15014
0407-2223-19Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-21Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-21Visipaque200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20014
0407-2223-50Visipaque50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5014
0407-2223-50Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-51Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-51Visipaque100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10014
0407-2223-53Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-53Visipaque200 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION20014
0407-2223-54Visipaque50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5014
0407-2223-54Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-55Visipaque100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10014
0407-2223-55Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-56Visipaque150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15014
0407-2223-56Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-57Visipaque10 in 1 BOXINJECTION, SOLUTION1014
0407-2223-57Visipaque200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-2223-01ML - Milliliter0407-22233002ac38-421f-4723-a335-c805eb4212c712012-07-24
0407-2223-02ML - Milliliter0407-2223df22b48f-10e2-4dcf-ad45-80b266f8bda412012-07-24
0407-2223-03ML - Milliliter0407-222320efb52c-4c0b-4ec5-b4b8-48e018d0e0da12012-07-24
0407-2223-04ML - Milliliter0407-2223a6c034ed-bc88-4207-881d-b105e397960412012-07-24
0407-2223-06ML - Milliliter0407-2223f7e43066-1005-427d-aaca-711d9cad313612012-07-24
0407-2223-16ML - Milliliter0407-2223bc8278c0-1bfa-4688-88f3-6a767b65b08e12012-07-24
0407-2223-17ML - Milliliter0407-22233f4a9f11-9d4b-4b52-916a-15a24590e40712012-07-24
0407-2223-19ML - Milliliter0407-2223cea613b0-a150-40e3-9243-ce9b901a276b12012-07-24
0407-2223-21ML - Milliliter0407-22238e2d4ad3-4968-4c43-b7e3-062f7dcbf59e12012-07-24
0407-2223-23ML - Milliliter0407-22235d54affd-52a2-4232-aad9-ad6bea96e18312013-02-13
0407-2223-35ML - Milliliter0407-222379a90c39-e5b4-4b18-9645-c4061a21eeaa12013-02-11
0407-2223-55ML - Milliliter0407-2223beefb2a8-6fe4-4637-bcea-65c2abed1bcc12017-04-05
0407-2223-60ML - Milliliter0407-2223f9949d44-4b02-4328-9fac-464c74aaf74812012-07-24
0407-2223-61ML - Milliliter0407-22231cb0bf6d-9bb4-4546-a3a0-78301c1ba6ba12012-07-24
0407-2223-62ML - Milliliter0407-222316ae9147-3c7a-4e7d-8094-b4a33fb02b6212012-07-24
0407-2223-63ML - Milliliter0407-22233a520462-5bba-4ebb-aa89-57932302824412012-07-24
0407-2223-64ML - Milliliter0407-222392451ab3-e52e-4312-8e1c-2b1b0109765d12012-07-24
0407-2223-65ML - Milliliter0407-222354262feb-5408-4aab-85a5-f01b34014dd012012-07-24
0407-2223-66ML - Milliliter0407-2223f9f1e40a-08a5-45e8-897b-724d75cd29f212012-07-24
0407-2223-67ML - Milliliter0407-22237bcb74a0-5304-4994-a02a-c9f19a25c63212012-07-24

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
0407-2223VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]15Current NDC, Legacy NDC, 4 package rows20230515_2d964c13-88ad-43be-88d4-a3a7ea4d5b5e.zip
0407-2223VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]13Current NDC, Legacy NDC, 32 package rows20230506_e9d87b8c-7695-4c0f-8e81-000dedb5f66d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0407-2223-010040722230150 mL in 1 VIAL50 mlHistorical
0407-2223-020040722230210 BOTTLE, GLASS in 1 BOX (0407-2223-02) > 100 mL in 1 BOTTLE, GLASS2003-09-090000-00-00NoNoCurrent
0407-2223-030040722230310 in 1 BOXHistorical
0407-2223-040040722230410 in 1 BOXHistorical
0407-2223-060040722230650 mL in 1 BOTTLE, GLASS50 mlHistorical
0407-2223-160040722231610 BOTTLE, PLASTIC in 1 BOX (0407-2223-16) / 50 mL in 1 BOTTLE, PLASTIC2003-09-090000-00-00NoNoCurrent
0407-2223-170040722231710 BOTTLE, PLASTIC in 1 BOX (0407-2223-17) / 100 mL in 1 BOTTLE, PLASTIC2003-09-090000-00-00NoNoCurrent
0407-2223-190040722231910 BOTTLE, PLASTIC in 1 BOX (0407-2223-19) / 150 mL in 1 BOTTLE, PLASTIC2003-09-090000-00-00NoNoCurrent
0407-2223-210040722232110 BOTTLE, PLASTIC in 1 BOX (0407-2223-21) / 200 mL in 1 BOTTLE, PLASTIC2003-09-090000-00-00NoNoCurrent
0407-2223-230040722232310 BOTTLE, PLASTIC in 1 BOX (0407-2223-23) / 500 mL in 1 BOTTLE, PLASTIC2006-05-010000-00-00NoNoCurrent
0407-2223-500040722235050 mL in 1 BOTTLE, GLASS50 mlHistorical
0407-2223-510040722235110 in 1 BOXHistorical
0407-2223-530040722235310 in 1 BOXHistorical
0407-2223-540040722235450 mL in 1 BOTTLE, PLASTIC50 mlHistorical
0407-2223-5500407222355100 mL in 1 BOTTLE, PLASTIC100 mlHistorical
0407-2223-5600407222356150 mL in 1 BOTTLE, PLASTIC150 mlHistorical
0407-2223-570040722235710 in 1 BOXHistorical
0407-2223-5800407222358500 mL in 1 BOTTLE, PLASTIC500 mlHistorical
0407-2223-620040722236210 BOTTLE, PLASTIC in 1 BOX (0407-2223-62) > 50 mL in 1 BOTTLE, PLASTIC2010-06-010000-00-00NoNoCurrent
0407-2223-640040722236410 BOTTLE, PLASTIC in 1 BOX (0407-2223-64) > 100 mL in 1 BOTTLE, PLASTIC2010-06-010000-00-00NoNoCurrent
0407-2223-660040722236610 BOTTLE, PLASTIC in 1 BOX (0407-2223-66) > 150 mL in 1 BOTTLE, PLASTIC2010-06-010000-00-00NoNoCurrent
0407-2223-670040722236710 BOTTLE, PLASTIC in 1 BOX (0407-2223-67) > 200 mL in 1 BOTTLE, PLASTIC2010-06-010000-00-00NoNoCurrent