Ella

Product NDC: 50102-911
11-digit product format: 501020911
Labeler code: 50102
Product ID: 50102-911_d6ca82aa-9488-4aa7-a5f1-69873ecb8d0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ulipristal acetate
Dosage form: TABLET
Route: ORAL
Labeler: Afaxys Pharma LLC
Application: NDA022474
Marketing category: NDA
Marketing start: 2010-08-13
Marketing end: 0000-00-00
Substance: ULIPRISTAL ACETATE
Active strength: 30 mg/1
Pharmacologic classes: Progesterone Agonist/Antagonist [EPC],Selective Progesterone Receptor Modulators [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50102-911		D	Discontinued by firm		2026-08-17
excluded package	package	50102-911	50102-911-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50102-911-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50102-911-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50102-911-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50102-911-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50102-911-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50102-911-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50102-911-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50102-911-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50102-911-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50102-911-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50102-911-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50102-911-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022474-001	ELLA	ULIPRISTAL ACETATE	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022474-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022474-001	9844510	2028-12-08		Drug product	2019-04-18
N022474-001	8735380	2029-02-20		Drug product	2014-06-13
N022474-001	10159681	2030-04-13	U-2510		2019-04-18
N022474-001	10772897	2030-04-13	U-2958		2020-10-14
N022474-001	9283233	2030-04-13	U-1821		2016-03-16
N022474-001	8512745	2030-06-02		Drug product	2013-09-12
N022474-001	8426392	2030-06-12	U-1389		2013-05-07
N022474-001	8962603	2030-06-12	U-1657		2015-02-25

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 · 42 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
2026-08-18 06:07:40	2026-07	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022474-001	ELLA	30MG	TABLET / ORAL	AB	RLD, RS	2010-08-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022474-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022474-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022474-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022474-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022474-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022474-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022474-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022474-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022474-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022474-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022474-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022474-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022474-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022474-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022474-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022474-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022474-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022474-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022474-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022474-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022474-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022474-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022474-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022474-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022474-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022474-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022474-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022474-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022474-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022474-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022474-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022474-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022474-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022474-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022474-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022474-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022474-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022474-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 331 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	9844510	2028-12-08		Drug product	2019-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	8735380	2029-02-20		Drug product	2014-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	10159681	2030-04-13	U-2510		2019-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	10772897	2030-04-13	U-2958		2020-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	9283233	2030-04-13	U-1821		2016-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	8512745	2030-06-02		Drug product	2013-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	8426392	2030-06-12	U-1389		2013-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022474-001	8962603	2030-06-12	U-1657		2015-02-25	`fd3edfee7708…`

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	N022474-001	M-271	2024-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022474-001	M-271	2024-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022474-001	M-271	2024-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022474-001	M-271	2024-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022474-001	M-271	2024-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022474-001	M-271	2024-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022474-001	M-271	2024-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022474-001	M-271	2024-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022474-001	M-271	2024-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022474-001	M-271	2024-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022474-001	M-271	2024-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022474-001	M-271	2024-06-24	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022474-001	M-271	2024-06-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022474-001	M-271	2024-06-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022474-001	M-271	2024-06-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022474-001	M-271	2024-06-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022474-001	M-271	2024-06-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022474-001	M-271	2024-06-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022474-001	M-271	2024-06-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022474-001	M-271	2024-06-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022474-001	M-271	2024-06-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022474-001	M-271	2024-06-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022474-001	M-271	2024-06-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022474-001	M-271	2024-06-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022474-001	M-271	2024-06-24	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e4780ec-bddd-4be9-81f2-6de14b4e7739	Product name	1	20170504

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50102-911-01	2023-02-16	C162847	48780-1	f386c649-df45-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ella safely and effectively. See full prescribing information for ella. ELLA (ulipristal acetate) tablet,for oral use Initial U.S. Approval: 2010
50102-911-01	2023-01-30	C162847	48780-1	f386c649-df45-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ella safely and effectively. See full prescribing information for ella. ELLA (ulipristal acetate) tablet,for oral use Initial U.S. Approval: 2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50102-911-01	EA - Each	50102-911	827374c9-33ef-4d49-910f-c1d1c11f6213	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ULIPRISTAL ACETATE	ACTIVE INGREDIENT	YF7V70N02B	ELLA (ULIPRISTAL ACETATE) TABLET [AFAXYS INC.]	2
ULIPRISTAL	ACTIVE MOIETY	6J5J15Q2X8	ELLA (ULIPRISTAL ACETATE) TABLET [AFAXYS INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ELLA (ULIPRISTAL ACETATE) TABLET [AFAXYS INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ELLA (ULIPRISTAL ACETATE) TABLET [AFAXYS INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ELLA (ULIPRISTAL ACETATE) TABLET [AFAXYS INC.]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	ELLA (ULIPRISTAL ACETATE) TABLET [AFAXYS INC.]	2

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
Ella	ULIPRISTAL ACETATE	PMI Branded Pharmaceuticals, Inc.	2bf93d23-cddd-4613-9066-5b5fa090404b	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022474 application number: NDA022474
Ella	ULIPRISTAL ACETATE	A-S Medication Solutions	e5f09468-7ac8-40ba-a85b-758a32f586c3	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022474 application number: NDA022474

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YF7V70N02B	ULIPRISTAL ACETATE	126784-99-4	ULIPRISTAL ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1005928	Ella 30 MG Oral Tablet	PSN	4bc8f664-d3af-4ca5-8bbd-7d120da8027d	12
1005924	ulipristal acetate 30 MG Oral Tablet	PSN	4bc8f664-d3af-4ca5-8bbd-7d120da8027d	12
1005928	ulipristal acetate 30 MG Oral Tablet [Ella]	SBD	4bc8f664-d3af-4ca5-8bbd-7d120da8027d	12
1005924	ulipristal acetate 30 MG Oral Tablet	SCD	4bc8f664-d3af-4ca5-8bbd-7d120da8027d	12
1005928	Ella 30 MG Oral Tablet	SY	4bc8f664-d3af-4ca5-8bbd-7d120da8027d	12
1005928	Ella 30 MG Oral Tablet	PSN	04bb31a9-1682-4941-a7cb-a6526d226776	5
1005924	ulipristal acetate 30 MG Oral Tablet	PSN	04bb31a9-1682-4941-a7cb-a6526d226776	5
1005928	ulipristal acetate 30 MG Oral Tablet [Ella]	SBD	04bb31a9-1682-4941-a7cb-a6526d226776	5
1005924	ulipristal acetate 30 MG Oral Tablet	SCD	04bb31a9-1682-4941-a7cb-a6526d226776	5
1005928	Ella 30 MG Oral Tablet	SY	04bb31a9-1682-4941-a7cb-a6526d226776	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50102-911-01	50102091101	1 BLISTER PACK in 1 CARTON (50102-911-01) > 1 TABLET in 1 BLISTER PACK	1 blister pack	2010-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ella	A-S Medication Solutions	2021-03-01	HUMAN PRESCRIPTION DRUG LABEL	12
Ella	RPK Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	5
Ella	Afaxys Pharma LLC \| Laboratoire HRA Pharma \| Crystal Pharma, SAU \| Laboratorios Leon Farma S.A. \| Delpharm Lille S.A.S. \| CENEXI	2020-01-27	HUMAN PRESCRIPTION DRUG LABEL	12