Ella

Product NDC: 50090-5422
11-digit product format: 500905422
Labeler code: 50090
Product ID: 50090-5422_cb78d0c3-de38-40ed-a74b-8391b860e1cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ulipristal acetate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA022474
Marketing category: NDA
Marketing start: 2020-05-11
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ULIPRISTAL ACETATE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YF7V70N02B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1005924	Internal RxNorm lookup
1005928	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
e5f09468-7ac8-40ba-a85b-758a32f586c3	Available on FDA.report

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
50090-5422-0	2023-02-07	C162847	48780-1	f386c649-bb14-0266-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
50090-5422-0	2023-01-30	C162847	48780-1	f386c649-bb14-0266-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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5422-0	Ella	1 in 1 CARTON	TABLET	1		3
50090-5422-0	Ella	1 in 1 BLISTER PACK	TABLET	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5422-0	EA - Each	50090-5422	a1b9eadb-33a9-4110-bacb-10eda9e1f3b9	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5422	ELLA (ULIPRISTAL ACETATE) TABLET [A-S MEDICATION SOLUTIONS]	3	Current NDC, Legacy NDC, 2 package rows	20230208_e5f09468-7ac8-40ba-a85b-758a32f586c3.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
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 ndc (product): 50090-5422

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	e5f09468-7ac8-40ba-a85b-758a32f586c3	3
1005924	ulipristal acetate 30 MG Oral Tablet	PSN	e5f09468-7ac8-40ba-a85b-758a32f586c3	3
1005928	ulipristal acetate 30 MG Oral Tablet [Ella]	SBD	e5f09468-7ac8-40ba-a85b-758a32f586c3	3
1005924	ulipristal acetate 30 MG Oral Tablet	SCD	e5f09468-7ac8-40ba-a85b-758a32f586c3	3
1005928	Ella 30 MG Oral Tablet	SY	e5f09468-7ac8-40ba-a85b-758a32f586c3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5422-0	50090542200	1 BLISTER PACK in 1 CARTON (50090-5422-0) / 1 TABLET in 1 BLISTER PACK	1 blister pack	2021-01-06	0000-00-00	No	No	Current