Mifepristone

Product NDC: 0591-4390
11-digit product format: 005914390
Labeler code: 0591
Product ID: 0591-4390_57067545-4dd0-4ab0-ba97-d17d74fe7d69
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mifepristone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA211436
Marketing category: ANDA
Marketing start: 2024-01-19
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
A211436-001	MIFEPRISTONE	MIFEPRISTONE	300MG	TABLET / ORAL	AB		2020-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211436-001	AB

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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211436-001	MIFEPRISTONE	300MG	TABLET / ORAL	AB	2020-08-03	`a50c72e98297…`

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	A211436-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211436-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211436-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211436-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211436-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211436-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211436-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211436-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211436-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211436-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211436-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211436-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211436-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211436-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211436-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211436-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211436-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211436-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211436-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211436-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211436-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211436-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211436-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211436-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211436-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211436-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211436-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211436-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211436-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211436-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211436-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211436-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211436-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211436-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211436-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211436-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211436-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211436-001	PC	2024-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211436-001	PC	2024-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211436-001	PC	2024-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211436-001	PC	2024-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211436-001	PC	2024-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211436-001	PC	2024-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211436-001	PC	2024-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211436-001	PC	2024-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211436-001	PC	2024-07-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211436-001	PC	2024-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211436-001	PC	2024-07-17	`1c564ffb4f44…`

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
5e09acc0-fd26-4722-b8b3-46e560390d47	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
0591-4390-96	Mifepristone	28 in 1 BOTTLE	TABLET, FILM COATED	28		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-4390-96	EA - Each	0591-4390	3de25718-191d-4a7a-aeb5-756cf34c3c4b	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-4390	MIFEPRISTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	1	Current NDC, 1 package rows	20240120_5e09acc0-fd26-4722-b8b3-46e560390d47.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mifepristone	MIFEPRISTONE	Actavis Pharma, Inc.	5e09acc0-fd26-4722-b8b3-46e560390d47	2022-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211436 application number: ANDA211436 ndc (product): 0591-4390

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	5e09acc0-fd26-4722-b8b3-46e560390d47	1
1245262	mifepristone 300 MG Oral Tablet	SCD	5e09acc0-fd26-4722-b8b3-46e560390d47	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0591-4390-96	00591439096	28 TABLET, FILM COATED in 1 BOTTLE (0591-4390-96)	2024-01-19	No	No	Current