National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 02:10:49
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76346-073-01 | EA - Each | 76346-073 | 862ad7a1-c2be-4ee2-94d9-ffdf49cd7ec1 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76346-073 | 76346-073-01 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202107-001 | KORLYM | MIFEPRISTONE | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N202107-001 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202107-001 | 8921348 | 2028-08-27 | U-1643 | 2015-01-27 | |
| N202107-001 | 10842801 | 2032-11-15 | U-1643 | 2020-11-24 | |
| N202107-001 | 10500216 | 2033-03-05 | U-1643 | 2019-12-10 | |
| N202107-001 | 10166242 | 2036-04-20 | U-1643 | 2019-01-02 | |
| N202107-001 | 10166243 | 2036-04-20 | U-1643 | 2019-01-02 | |
| N202107-001 | 10660904 | 2036-04-20 | U-1643 | 2020-05-29 | |
| N202107-001 | 9943526 | 2036-04-20 | U-1643 | 2018-04-17 | |
| N202107-001 | 10006924 | 2036-08-12 | U-1643 | 2018-07-10 | |
| N202107-001 | 10495650 | 2036-08-12 | U-1643 | 2019-12-03 | |
| N202107-001 | 9829495 | 2036-08-15 | U-1643 | 2017-11-28 | |
| N202107-001 | 10151763 | 2037-01-18 | U-1643 | 2018-12-12 | |
| N202107-001 | 10195214 | 2037-06-19 | U-1643 | 2019-02-05 | |
| N202107-001 | 10842800 | 2037-06-19 | U-1643 | 2020-11-24 | |
| N202107-001 | 11969435 | 2037-06-19 | U-1643 | 2024-05-29 | |
| N202107-001 | 12097210 | 2037-06-19 | U-1643 | 2024-09-25 | |
| N202107-001 | 10231983 | 2038-08-22 | U-1643 | 2019-04-03 | |
| N202107-001 | 10314850 | 2038-08-22 | U-1643 | 2019-06-14 | |
| N202107-001 | 10780097 | 2038-08-22 | U-1643 | 2020-09-24 |
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 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | RLD, RS | 2012-02-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | RLD, RS | 2012-02-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | RLD, RS | 2012-02-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | RLD, RS | 2012-02-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N202107-001 | KORLYM | 300MG | TABLET / ORAL | AB | RLD, RS | 2012-02-17 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N202107-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202107-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N202107-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202107-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202107-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202107-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202107-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202107-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202107-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N202107-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202107-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202107-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202107-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N202107-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202107-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N202107-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N202107-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N202107-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N202107-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202107-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N202107-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N202107-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202107-001 | AB | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202107-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N202107-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N202107-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202107-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202107-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202107-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202107-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N202107-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N202107-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202107-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N202107-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N202107-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N202107-001 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N202107-001 | AB | 1 | a50c72e98297… |
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 | N202107-001 | 8921348 | 2028-08-27 | U-1643 | 2015-01-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10842801 | 2032-11-15 | U-1643 | 2020-11-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10500216 | 2033-03-05 | U-1643 | 2019-12-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10166242 | 2036-04-20 | U-1643 | 2019-01-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10166243 | 2036-04-20 | U-1643 | 2019-01-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10660904 | 2036-04-20 | U-1643 | 2020-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 9943526 | 2036-04-20 | U-1643 | 2018-04-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10006924 | 2036-08-12 | U-1643 | 2018-07-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10495650 | 2036-08-12 | U-1643 | 2019-12-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 9829495 | 2036-08-15 | U-1643 | 2017-11-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10151763 | 2037-01-18 | U-1643 | 2018-12-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10195214 | 2037-06-19 | U-1643 | 2019-02-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10842800 | 2037-06-19 | U-1643 | 2020-11-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 11969435 | 2037-06-19 | U-1643 | 2024-05-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 12097210 | 2037-06-19 | U-1643 | 2024-09-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10231983 | 2038-08-22 | U-1643 | 2019-04-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10314850 | 2038-08-22 | U-1643 | 2019-06-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202107-001 | 10780097 | 2038-08-22 | U-1643 | 2020-09-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 8921348 | 2028-08-27 | U-1643 | 2015-01-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10842801 | 2032-11-15 | U-1643 | 2020-11-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10500216 | 2033-03-05 | U-1643 | 2019-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10166242 | 2036-04-20 | U-1643 | 2019-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10166243 | 2036-04-20 | U-1643 | 2019-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10660904 | 2036-04-20 | U-1643 | 2020-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 9943526 | 2036-04-20 | U-1643 | 2018-04-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10006924 | 2036-08-12 | U-1643 | 2018-07-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10495650 | 2036-08-12 | U-1643 | 2019-12-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 9829495 | 2036-08-15 | U-1643 | 2017-11-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10151763 | 2037-01-18 | U-1643 | 2018-12-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10195214 | 2037-06-19 | U-1643 | 2019-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10842800 | 2037-06-19 | U-1643 | 2020-11-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 11969435 | 2037-06-19 | U-1643 | 2024-05-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 12097210 | 2037-06-19 | U-1643 | 2024-09-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10231983 | 2038-08-22 | U-1643 | 2019-04-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10314850 | 2038-08-22 | U-1643 | 2019-06-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202107-001 | 10780097 | 2038-08-22 | U-1643 | 2020-09-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202107-001 | 8921348 | 2028-08-27 | U-1643 | 2015-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202107-001 | 10842801 | 2032-11-15 | U-1643 | 2020-11-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202107-001 | 10500216 | 2033-03-05 | U-1643 | 2019-12-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202107-001 | 10166242 | 2036-04-20 | U-1643 | 2019-01-02 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N202107-001 | ODE-22 | 2019-02-17 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N202107-001 | ODE-22 | 2019-02-17 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N202107-001 | ODE-22 | 2019-02-17 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N202107-001 | ODE-22 | 2019-02-17 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Korlym | MIFEPRISTONE | Corcept Therapeutics Incorporated | 542f3fae-8bc8-4f00-9228-e4b66c9ad6a9 | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | 76346-073-01 76346007301 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.