Ella

Product NDC: 53002-2630
11-digit product format: 530022630
Labeler code: 53002
Product ID: 53002-2630_28822df7-626a-43a0-8648-7ca0cc7b5c0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ulipristal acetate
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA022474
Marketing category: NDA
Marketing start: 2020-05-11
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: 2023-12-31
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	53002-2630		I	Inactivated by FDA		2026-08-17
excluded package	package	53002-2630	53002-2630-1	I	Inactivated by FDA		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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-2630-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-2630-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-2630-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-2630-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-2630-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-2630-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2630-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2630-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2630-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
53002-2630-1	2025-01-30	C162847	48780-1	2cef2736-5ca1-d83d-e063-dadaa90ab31f	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
53002-2630-1	Ella	1 in 1 BLISTER PACK	TABLET	1		1
53002-2630-1	Ella	1 in 1 CARTON	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2630	ELLA (ULIPRISTAL ACETATE) TABLET [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 2 package rows	20220331_c775958f-9ea3-4a5c-9915-794d844e4024.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

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	c775958f-9ea3-4a5c-9915-794d844e4024	1
1005924	ulipristal acetate 30 MG Oral Tablet	PSN	c775958f-9ea3-4a5c-9915-794d844e4024	1
1005928	ulipristal acetate 30 MG Oral Tablet [Ella]	SBD	c775958f-9ea3-4a5c-9915-794d844e4024	1
1005924	ulipristal acetate 30 MG Oral Tablet	SCD	c775958f-9ea3-4a5c-9915-794d844e4024	1
1005928	Ella 30 MG Oral Tablet	SY	c775958f-9ea3-4a5c-9915-794d844e4024	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2630-1	53002263001	1 BLISTER PACK in 1 CARTON (53002-2630-1) > 1 TABLET in 1 BLISTER PACK	1 blister pack	2022-08-01	0000-00-00	No	No	Current