NDC 54702-501
ORALTAG
Iohexol
ORALTAG is a Oral For Solution in the Human Prescription Drug category. It is labeled and distributed by Interpharma Praha, A.s.. The primary component is Iohexol.
| Product ID | 54702-501_7ac86b61-b1ca-f0eb-e053-2a91aa0a8068 |
| NDC | 54702-501 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ORALTAG |
| Generic Name | Iohexol |
| Dosage Form | For Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-07-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA205383 |
| Labeler Name | Interpharma Praha, a.s. |
| Substance Name | IOHEXOL |
| Active Ingredient Strength | 5 g/1 |
| Pharm Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 54702-501-52
12 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)
| Marketing Start Date | 2016-07-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 54702-501-51 [54702050151]
ORALTAG FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-04-16 |
NDC 54702-501-20 [54702050120]
ORALTAG FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-01 |
| Marketing End Date | 2015-04-16 |
NDC 54702-501-98 [54702050198]
ORALTAG FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-01 |
NDC 54702-501-62 [54702050162]
ORALTAG FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-01 |
NDC 54702-501-21 [54702050121]
ORALTAG FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-04-16 |
NDC 54702-501-99 [54702050199]
ORALTAG FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2015-04-16 |
NDC 54702-501-52 [54702050152]
ORALTAG FOR SOLUTION
| Marketing Category | NDA |
| Application Number | NDA205383 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2016-07-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOHEXOL | 4.5 g/1 |
OpenFDA Data
| SPL SET ID: | fdeb1668-7126-48f7-aaf9-1dc3beb90bac |
| Manufacturer | |
| UNII |
Pharmacological Class
- Radiographic Contrast Agent [EPC]
- X-Ray Contrast Activity [MoA]
NDC Crossover Matching brand name "ORALTAG" or generic name "Iohexol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 54702-501 | ORALTAG | ORALTAG |
| 0407-1401 | OMNIPAQUE | Iohexol |
| 0407-1411 | OMNIPAQUE | Iohexol |
| 0407-1412 | OMNIPAQUE | Iohexol |
| 0407-1413 | Omnipaque | Iohexol |
| 0407-1414 | Omnipaque | Iohexol |
Trademark Results [ORALTAG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORALTAG 85932311 5045866 Live/Registered |
Otsuka Pharmaceutical Co., Ltd. 2013-05-15 |
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