Osphena

Product NDC: 59630-580
11-digit product format: 596300580
Labeler code: 59630
Product ID: 59630-580_0b4d6807-eb1c-4b86-9ee0-408fcdb55882
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ospemifene
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Shionogi Inc.
Application: NDA203505
Marketing category: NDA
Marketing start: 2013-02-26
Marketing end: 0000-00-00
Substance: OSPEMIFENE
Active strength: 60 mg/1
Pharmacologic classes: Estrogen Agonist/Antagonist [EPC], Selective Estrogen 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59630-580		D	Discontinued by firm	2026-08-17
excluded package	package	59630-580	59630-580-18	D	Discontinued by firm	2026-08-17
excluded package	package	59630-580	59630-580-55	D	Discontinued by firm	2026-08-17
excluded package	package	59630-580	59630-580-90	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 · 30 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	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59630-580-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59630-580-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59630-580-55	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59630-580-18	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	59630-580-11	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
N203505-001	OSPHENA	OSPEMIFENE	60MG	TABLET / ORAL		RLD, RS	2013-02-26

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203505-001	8236861	2026-08-11	U-1369		2013-03-25
N203505-001	8236861	2026-08-11	U-1370		2013-03-25
N203505-001	8236861	2026-08-11	U-905		2013-03-25
N203505-001	8642079	2028-07-09		Drug product	2014-02-20

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	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203505-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203505-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203505-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203505-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203505-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203505-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203505-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203505-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203505-001	AB	1	`6a51e52b5d6a…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 683 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	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	6245819	2025-07-21	U-905		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	6245819	2025-07-21	U-1370		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203505-001	6245819	2025-07-21	U-905		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	6245819	2025-07-21	U-1370		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	6245819	2025-07-21	U-905		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	6245819	2025-07-21	U-1370		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	6245819	2025-07-21	U-905		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	6245819	2025-07-21	U-1370		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8470890	2024-02-13	U-905			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8470890	2024-02-13	U-1370			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8470890	2024-02-13	U-1369			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8772353	2024-02-13	U-1370		2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8772353	2024-02-13	U-905		2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8772353	2024-02-13	U-1369		2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	9241915	2024-02-13	U-1369		2016-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	9241915	2024-02-13	U-1370		2016-02-10	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203505-001	I-793	2022-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203505-001	I-793	2022-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203505-001	I-793	2022-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203505-001	I-793	2022-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203505-001	I-793	2022-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203505-001	I-793	2022-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203505-001	I-793	2022-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203505-001	I-793	2022-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203505-001	I-793	2022-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203505-001	I-793	2022-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203505-001	I-793	2022-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203505-001	I-793	2022-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203505-001	I-793	2022-01-25	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N203505-001	I-793	2022-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203505-001	I-793	2022-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203505-001	I-793	2022-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203505-001	I-793	2022-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203505-001	I-793	2022-01-25	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59630-580-30	EA - Each	59630-580	301c619d-a2d1-47ae-8adc-dafd3fcc54f9	1	2013-05-02
59630-580-90	EA - Each	59630-580	eeed97bf-969f-47dd-b956-236e9042ff8a	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OSPEMIFENE	ACTIVE INGREDIENT	B0P231ILBK	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
OSPEMIFENE	ACTIVE MOIETY	B0P231ILBK	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59630-580	OSPHENA (OSPEMIFENE) TABLET, FILM COATED [SHIONOGI INC.]	27	Legacy NDC	20230322_8462d6ab-e3cd-4efa-a360-75bf8f917287.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
Osphena	OSPEMIFENE	Duchesnay USA, Inc.	9accbcc9-78ee-4f84-9b7e-704f2ab1c413	2025-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203505 application number: NDA203505

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
B0P231ILBK	OSPEMIFENE	128607-22-7	OSPEMIFENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59630-580-18	59630058018	1 BLISTER PACK in 1 PACKAGE (59630-580-18) > 15 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2017-04-15	0000-00-00	No	No	Current
59630-580-55	59630058055	1 BLISTER PACK in 1 PACKAGE (59630-580-55) > 5 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2017-04-15	0000-00-00	No	No	Current
59630-580-90	59630058090	90 TABLET, FILM COATED in 1 BOTTLE (59630-580-90)		2013-02-26	0000-00-00	No	No	Current