Application 021693
- Type
- NDA
- Sponsor
- SHIONOGI INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYBIX ODT | TRAMADOL HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021693-001 | RYBIX ODT | TRAMADOL HYDROCHLORIDE | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021693-001 | RYBIX ODT | 50MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2005-05-05 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 9f0e33bd-65f8-446a-886f-e7e16a142ce5 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 16053b28-c759-4914-93e6-2de0afe72445 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 42de8c3a-0441-5d46-e063-6294a90a2079 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 6bb5be12-59ff-40f4-9841-9c7ab93be2ea | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 552e5b32-accf-29dd-e063-6294a90a4fcf | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Northwind Health Company, LLC | 552955e6-2bb3-8755-e063-6394a90ab21c | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Coupler LLC | 54d74939-301b-e603-e063-6394a90a3b03 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 515baa9a-b226-4bbe-be87-f9befdf1c9e1 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | 5199132e-745e-46a0-8068-e06d1bca5c61 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 855905c7-1481-4b2d-a318-3254ad8ed73c | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Proficient Rx LP | aefc85bc-0820-4aee-8d94-313c5f1658f5 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Major Pharmaceuticals | 6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 66359f41-9999-4cb8-b632-1fe2ec1e60b2 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 43fe10b2-17a4-4dc2-9a48-2378547b61fd | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | f2f421ab-35ae-7637-e053-2995a90a40e0 | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | 674803a0-4cf5-4416-a5e3-c1a1e332cdcd | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | acd5d8e0-a4cc-4654-ae04-faff347a60ca | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| Tramadol Hydrochloride | TRAMADOL HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | 007bf37f-0e46-426a-ac8c-be63d4b7414c | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | Bryant Ranch Prepack | a77b0dba-8ac7-418a-b435-16a0e6c22804 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | REMEDYREPACK INC. | b76c1366-f6c0-42ad-bb19-2b72a91490e4 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | TRAMADOL HYDROCHLORIDE |