ORALTAG

Product NDC
54702-501
11-digit product format
547020501
Labeler code
54702
Product ID
54702-501_f18b8a5a-9bfe-329c-e053-2995a90af8f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iohexol
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
Interpharma Praha, a.s.
Application
NDA205383
Marketing category
NDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
IOHEXOL
Active strength
5 g/1
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54702-501IInactivated by FDA2026-09-14
excluded packagepackage54702-50154702-501-52IInactivated by FDA2026-09-14
excluded packagepackage54702-50154702-501-62IInactivated by FDA2026-09-14
excluded packagepackage54702-50154702-501-98IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54702-501-62IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54702-501-98IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54702-501-52IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54702-501-62IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54702-501-98IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54702-501-52IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54702-501-62IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54702-501-98IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54702-501-52IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54702-501-62IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54702-501-98IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54702-501-52IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54702-501-62IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54702-501-98IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54702-501-52IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54702-501-62IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54702-501-98IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54702-501-52IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54702-501-52UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54702-501-98UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54702-501-62UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54702-501-52UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54702-501-98UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54702-501-62UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54702-501-52UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54702-501-98UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54702-501-62UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54702-501-62IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54702-501-98IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54702-501-52IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54702-501-62IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54702-501-98IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54702-501-52IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54702-501-62IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54702-501-98IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54702-501-52IInactivated by FDAbd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205383-001ORALTAGIOHEXOL9.7GM/BOTFOR SOLUTION / ORAL2015-03-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-2684e616aacf4f…
2026-08-18 06:07:402026-07N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-263f01610625f2…
2019-09-15 20:21 UTC2019-09N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205383-001ORALTAG9.7GM/BOTFOR SOLUTION / ORAL2015-03-26f41ea6bd6efb…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54702-501-522025-01-30These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985
54702-501-622025-01-30These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985
54702-501-982025-01-30These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985
54702-501-522023-01-05These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985
54702-501-622023-01-05These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985
54702-501-982023-01-05These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985
54702-501-522022-01-28These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985
54702-501-622022-01-28These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985
54702-501-982022-01-28These highlights do not include all the information needed to use ORALTAG safely and effectively. See full prescribing information for ORALTAG. ORALTAG™ (iohexol) for oral solution Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54702-501-21ORALTAG1 in 1 BOTTLE, PLASTICFOR SOLUTION117
54702-501-51ORALTAG1 in 1 POUCHFOR SOLUTION117
54702-501-52ORALTAG12 in 1 CASEFOR SOLUTION1217
54702-501-62ORALTAG25 in 1 CASEFOR SOLUTION2517
54702-501-98ORALTAG12 in 1 CASEFOR SOLUTION1217
54702-501-99ORALTAG1 in 1 POUCHFOR SOLUTION117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54702-501ORALTAG (IOHEXOL) FOR SOLUTION [INTERPHARMA PRAHA, A.S.]17Legacy NDC, 6 package rows20230107_fdeb1668-7126-48f7-aaf9-1dc3beb90bac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54702-501-21547020501211 in 1 BOTTLE, PLASTICHistorical
54702-501-51547020501511 in 1 POUCHHistorical
54702-501-525470205015212 POUCH in 1 CASE (54702-501-52) > 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-51) > 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21) 12 pouch2016-07-010000-00-00NoNoCurrent
54702-501-625470205016225 POUCH in 1 CASE (54702-501-62) > 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-51) > 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21) 25 pouch2016-07-010000-00-00NoNoCurrent
54702-501-985470205019812 POUCH in 1 CASE (54702-501-98) > 1 BOTTLE, PLASTIC in 1 POUCH (54702-501-99) > 1 FOR SOLUTION in 1 BOTTLE, PLASTIC (54702-501-21) 12 pouch2016-07-010000-00-00NoNoCurrent
54702-501-99547020501991 in 1 POUCHHistorical