Application 202020
- Type
- NDA
- Sponsor
- HORIZON PHARMA USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RAYOS | PREDNISONE | TABLET, DELAYED RELEASE;ORAL | 1MG | Yes | No |
| 002 | RAYOS | PREDNISONE | TABLET, DELAYED RELEASE;ORAL | 2MG | Yes | No |
| 003 | RAYOS | PREDNISONE | TABLET, DELAYED RELEASE;ORAL | 5MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202020-001 | RAYOS | PREDNISONE | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | |
| N202020-002 | RAYOS | PREDNISONE | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | |
| N202020-003 | RAYOS | PREDNISONE | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | |
| N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | |
| N202020-003 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | |
| N202020-003 | 8168218 | 2028-01-07 | U-1269 | Drug product | 2012-08-22 |
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 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2012-07-26 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2012-07-26 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2012-07-26 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2012-07-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2012-07-26 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2012-07-26 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2012-07-26 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2012-07-26 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202020-002 | RAYOS | 2MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2012-07-26 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202020-003 | RAYOS | 5MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2012-07-26 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202020-001 | RAYOS | 1MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2012-07-26 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202020-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202020-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202020-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-10-29 15:01 UTC | 2024-10 | N202020-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202020-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N202020-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202020-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202020-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202020-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202020-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202020-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202020-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202020-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202020-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202020-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202020-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202020-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N202020-003 | AB | 1 | 8072bd15b7f6… |
| 2019-12-13 00:20 UTC | 2019-12 | N202020-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N202020-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N202020-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N202020-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N202020-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N202020-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N202020-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N202020-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N202020-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N202020-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N202020-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N202020-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202020-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202020-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202020-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202020-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N202020-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N202020-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202020-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N202020-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N202020-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202020-001 | AB | 1 | a72a2bbeb626… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202020-003 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202020-003 | 8168218 | 2028-01-07 | U-1269 | Drug product | 2012-08-22 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202020-003 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202020-003 | 8168218 | 2028-01-07 | U-1269 | Drug product | 2012-08-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202020-003 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202020-003 | 8168218 | 2028-01-07 | U-1269 | Drug product | 2012-08-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202020-003 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202020-003 | 8168218 | 2028-01-07 | U-1269 | Drug product | 2012-08-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202020-003 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202020-003 | 8168218 | 2028-01-07 | U-1269 | Drug product | 2012-08-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202020-003 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202020-003 | 8168218 | 2028-01-07 | U-1269 | Drug product | 2012-08-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202020-003 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202020-003 | 8168218 | 2028-01-07 | U-1269 | Drug product | 2012-08-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-001 | 8309124 | 2024-04-23 | U-1292 | 2012-11-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-001 | 8394407 | 2024-04-23 | U-1362 | Drug product | 2013-03-12 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-001 | 9040085 | 2024-04-23 | U-1362 | 2015-06-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-001 | 9186332 | 2024-04-23 | U-1362 | 2015-12-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-001 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-002 | 8309124 | 2024-04-23 | 03ed91905a0d… | |||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-002 | 8394407 | 2024-04-23 | U-1362 | Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-002 | 9040085 | 2024-04-23 | U-1362 | 2015-06-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-002 | 9186332 | 2024-04-23 | U-1362 | 2015-12-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-002 | 9504699 | 2027-08-03 | U-1362 | 2016-12-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-003 | 8309124 | 2024-04-23 | U-1292 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202020-003 | 8394407 | 2024-04-23 | U-1362 | Drug product | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | Coupler LLC | 50734a48-807d-cc00-e063-6294a90a4dae | 2026-04-27 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Sportpharm LLC | 5dde7256-d3b8-400d-a0eb-c60078bfc5d9 | 2026-04-24 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Amneal Pharmaceuticals NY LLC | 0740ef68-7641-432e-bd46-4710687fc9d7 | 2026-04-14 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | REMEDYREPACK INC. | 4bd86b2f-75cb-4711-85e2-b81ed947cb13 | 2026-04-13 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | e9a74862-6a3b-4247-837a-389761b5c352 | 2026-04-13 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | b540f4af-8f07-4c56-b151-d759440c514a | 2026-04-13 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Bryant Ranch Prepack | 70d05ed7-5c4e-4cd1-84cd-0dbe90692c54 | 2026-04-09 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Northwind Health Company, LLC | fbd3f0c3-06b3-c9b4-e053-6294a90a6fdd | 2026-04-07 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 5 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e | 2026-03-27 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 20 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 3befbdc5-7d20-41b6-ad80-98e1c6b8caf5 | 2026-03-27 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | A-S Medication Solutions | 53c66f70-58fd-4d4c-b054-e5cefdc0c637 | 2026-03-26 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 5 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | d6df3295-3118-49af-be05-b1fab0d4adaa | 2026-03-25 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 10 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 14d50f54-410b-45b2-a639-31498ceaf854 | 2026-03-25 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | A-S Medication Solutions | b5b088b9-8f90-468f-b7a4-a5274aa0aec9 | 2026-03-19 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | DIRECT RX | 2a053775-6f6a-455e-b9a8-8b60e6062db3 | 2026-03-17 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | A-S Medication Solutions | e753e2bc-acca-46eb-888c-ae72fcac6ca4 | 2026-03-13 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | A-S Medication Solutions | a8f6298a-1084-4226-bfd9-a543a26ad2e7 | 2026-03-13 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 20 mg | PREDNISONE | Bryant Ranch Prepack | 852ea185-1bda-4c89-a192-ee0f93cba428 | 2026-03-11 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | A-S Medication Solutions | 71295010-5adb-499b-a03a-5c78b5e79b2d | 2026-03-07 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Asclemed USA, Inc. | fdcf3271-fae7-47ef-a370-adbdc0a3cf37 | 2026-03-03 | Warnings, Adverse reactions | PREDNISONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 75987-020 | RAYOS | prednisone | Horizon Pharma Inc. | NDA | Current |
| 75987-020 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-020 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-020 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-020 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-021 | RAYOS | prednisone | Horizon Pharma Inc. | NDA | Current |
| 75987-021 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-021 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-021 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-021 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-022 | RAYOS | prednisone | Horizon Pharma Inc. | NDA | Current |
| 75987-022 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-022 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-022 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-022 | RAYOS | prednisone | Horizon Therapeutics USA, Inc. | NDA | Current |