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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 54702-501 | I | Inactivated by FDA | 2026-09-14 | ||
| excluded package | package | 54702-501 | 54702-501-52 | I | Inactivated by FDA | 2026-09-14 | |
| excluded package | package | 54702-501 | 54702-501-62 | I | Inactivated by FDA | 2026-09-14 | |
| excluded package | package | 54702-501 | 54702-501-98 | I | Inactivated by FDA | 2026-09-14 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 54702-501-52 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 54702-501-98 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 54702-501-62 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 54702-501-52 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 54702-501-98 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 54702-501-62 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 54702-501-52 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 54702-501-98 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 54702-501-62 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 54702-501-62 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 54702-501-98 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 54702-501-52 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205383-001 | ORALTAG | IOHEXOL | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N205383-001 | ORALTAG | 9.7GM/BOT | FOR SOLUTION / ORAL | 2015-03-26 | f41ea6bd6efb… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5f30b278-5791-4113-8781-878a9221ef8a | Product name | 2 | 20230125 |
| 2a70c781-a755-4d76-b20a-a958acfbdcdc | Product name | 2 | 20190619 |
| 304592ef-4a8a-4c22-8e8c-af73aa3d60e5 | Product name | 1 | 20180703 |
| ac0821a1-ce75-4ea7-880a-59eecaecdf22 | Product name | 1 | 20180703 |
| db5dc4f9-b907-46f6-8fb7-babcf04bbe5c | Product name | 1 | 20180619 |
| 41e9d6cf-3ed7-4c44-a57e-0685058d0896 | Product name | 1 | 20170824 |
| 5e652c92-68fd-426b-b0e7-5fc64e0b9f99 | Product name | 1 | 20170309 |
| ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c | Product name | 1 | 20150421 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54702-501-21 | ORALTAG | 1 in 1 BOTTLE, PLASTIC | FOR SOLUTION | 1 | 17 | |
| 54702-501-51 | ORALTAG | 1 in 1 POUCH | FOR SOLUTION | 1 | 17 | |
| 54702-501-52 | ORALTAG | 12 in 1 CASE | FOR SOLUTION | 12 | 17 | |
| 54702-501-62 | ORALTAG | 25 in 1 CASE | FOR SOLUTION | 25 | 17 | |
| 54702-501-98 | ORALTAG | 12 in 1 CASE | FOR SOLUTION | 12 | 17 | |
| 54702-501-99 | ORALTAG | 1 in 1 POUCH | FOR SOLUTION | 1 | 17 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54702-501-21 | 54702050121 | 1 in 1 BOTTLE, PLASTIC | Historical | |||||
| 54702-501-51 | 54702050151 | 1 in 1 POUCH | Historical | |||||
| 54702-501-52 | 54702050152 | 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) | 12 pouch | 2016-07-01 | 0000-00-00 | No | No | Current |
| 54702-501-62 | 54702050162 | 25 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 pouch | 2016-07-01 | 0000-00-00 | No | No | Current |
| 54702-501-98 | 54702050198 | 12 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 pouch | 2016-07-01 | 0000-00-00 | No | No | Current |
| 54702-501-99 | 54702050199 | 1 in 1 POUCH | Historical |