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

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54702-501-522025-01-30C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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
54702-501-622025-01-30C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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
54702-501-982025-01-30C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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
54702-501-522023-01-05C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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
54702-501-622023-01-05C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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
54702-501-982023-01-05C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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
54702-501-522022-01-28C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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
54702-501-622022-01-28C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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
54702-501-982022-01-28C16284748780-1d6a99b39-80e7-a426-e053-dadaa90af4c2These 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