Mifepristone

Product NDC: 76346-654
11-digit product format: 763460654
Labeler code: 76346
Product ID: 76346-654_4b30c5df-70a3-418c-b2f4-26ab504eb0a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mifepristone
Dosage form: TABLET
Route: ORAL
Labeler: Corcept Therapeutics Incorporated
Application: NDA202107
Marketing category: NDA
Marketing start: 2024-05-28
Substance: MIFEPRISTONE
Active strength: 300 mg/1
Pharmacologic classes: Progestational Hormone Receptor Antagonists [MoA], Progestin Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
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#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N202107-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
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	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…`
2022-09-29 23:25 UTC	2022-09	N202107-001	KORLYM	300MG	TABLET / ORAL	AB	RLD, RS	2012-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202107-001	KORLYM	300MG	TABLET / ORAL	AB	RLD, RS	2012-02-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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#

Patent history page 1 of 17 · 656 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
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…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10166243	2036-04-20	U-1643	2019-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10660904	2036-04-20	U-1643	2020-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	9943526	2036-04-20	U-1643	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10006924	2036-08-12	U-1643	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10495650	2036-08-12	U-1643	2019-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	9829495	2036-08-15	U-1643	2017-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10151763	2037-01-18	U-1643	2018-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10195214	2037-06-19	U-1643	2019-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10842800	2037-06-19	U-1643	2020-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	11969435	2037-06-19	U-1643	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	12097210	2037-06-19	U-1643	2024-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10231983	2038-08-22	U-1643	2019-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10314850	2038-08-22	U-1643	2019-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202107-001	10780097	2038-08-22	U-1643	2020-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	8921348	2028-08-27	U-1643	2015-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10842801	2032-11-15	U-1643	2020-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10500216	2033-03-05	U-1643	2019-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10166242	2036-04-20	U-1643	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10166243	2036-04-20	U-1643	2019-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10660904	2036-04-20	U-1643	2020-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	9943526	2036-04-20	U-1643	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10006924	2036-08-12	U-1643	2018-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10495650	2036-08-12	U-1643	2019-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	9829495	2036-08-15	U-1643	2017-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10151763	2037-01-18	U-1643	2018-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10195214	2037-06-19	U-1643	2019-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10842800	2037-06-19	U-1643	2020-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	11969435	2037-06-19	U-1643	2024-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	12097210	2037-06-19	U-1643	2024-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10231983	2038-08-22	U-1643	2019-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10314850	2038-08-22	U-1643	2019-06-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202107-001	10780097	2038-08-22	U-1643	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202107-001	8921348	2028-08-27	U-1643	2015-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202107-001	10842801	2032-11-15	U-1643	2020-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202107-001	10500216	2033-03-05	U-1643	2019-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202107-001	10166242	2036-04-20	U-1643	2019-01-02	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mifepristone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIFEPRISTONE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
320T6RNW1F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1245262	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
63c068cd-9370-460f-829b-70e8c7ebe91e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9f80ed59-2511-7c3d-8726-727ad4e34951	Product name	2	20210223
d77d5635-fbfa-4e46-b227-bea7fc095975	Product name	1	20190710

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76346-654-03	Mifepristone	280 in 1 BOTTLE	TABLET	280		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76346-654-03	EA - Each	76346-654	9315bd11-18b9-4c54-8c65-0fd282fdcce2	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76346-654	MIFEPRISTONE TABLET [CORCEPT THERAPEUTICS INCORPORATED]	2	Current NDC, 1 package rows	20250130_63c068cd-9370-460f-829b-70e8c7ebe91e.zip

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mifepristone	MIFEPRISTONE	Corcept Therapeutics Incorporated	63c068cd-9370-460f-829b-70e8c7ebe91e	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202107 application number: NDA202107 ndc (product): 76346-654
Korlym	MIFEPRISTONE	Corcept Therapeutics Incorporated	542f3fae-8bc8-4f00-9228-e4b66c9ad6a9	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202107 application number: NDA202107

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
320T6RNW1F	MIFEPRISTONE	84371-65-3	MIFEPRISTONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1245262	miFEPRIStone 300 MG Oral Tablet	PSN	63c068cd-9370-460f-829b-70e8c7ebe91e	3
1245262	mifepristone 300 MG Oral Tablet	SCD	63c068cd-9370-460f-829b-70e8c7ebe91e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76346-654-03	76346065403	280 TABLET in 1 BOTTLE (76346-654-03)	280 tablet	2024-05-28	No	No	Current