FDA.reportPublic FDA data

NDC 54702-501-51 - ORALTAG

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
54702-501
Requested NDC
54702-501-51
Package NDCs from labels
54702-501-21, 54702-501-51, 54702-501-52, 54702-501-62, 54702-501-99, 54702-501-98
Manufacturer
Interpharma Praha, a.s.
Effective date
2023-01-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ORALTAG - Interpharma Praha, a.s.Interpharma Praha, a.s.2023-01-05HUMAN PRESCRIPTION DRUG LABEL

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IohexolIOHEXOLAmneal Pharmaceuticals Private Limitedff9456ef-c45a-450d-9004-a684af2bcc592026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4419T9MX03
OMNIPAQUEIOHEXOLMedical Purchasing Solutions, LLC5088be1d-a708-1cac-e063-6394a90a2aff2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4419T9MX03
OMNIPAQUEIOHEXOLMedical Purchasing Solutions, LLC508c42eb-f5e5-44f1-e063-6294a90a4d1f2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4419T9MX03
OMNIPAQUEIOHEXOLGE Healthcare Inc.eee15ebe-d349-4497-acef-6abe7a8247fb2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4419T9MX03
OmnipaqueIOHEXOLGE Healthcare164b27b9-97ae-4279-896f-1c4afa583dd12026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4419T9MX03
f18b8a5a-9bfe-329c-e053-2995a90af8f3fdeb1668-7126-48f7-aaf9-1dc3beb90bac2023-01-05Warnings, Adverse reactionsExact identifier
spl id: f18b8a5a-9bfe-329c-e053-2995a90af8f3
spl set id: fdeb1668-7126-48f7-aaf9-1dc3beb90bac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.