Orgovyx

Product NDC: 72974-120
11-digit product format: 729740120
Labeler code: 72974
Product ID: 72974-120_0d9200dd-878e-4e93-98af-e1149e84c21f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: relugolix
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sumitomo Pharma America, Inc.
Application: NDA214621
Marketing category: NDA
Marketing start: 2020-12-18
Substance: RELUGOLIX
Active strength: 120 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased GnRH Secretion [PE], Gonadotropin Releasing Hormone Receptor Antagonist [EPC], Gonadotropin Releasing Hormone Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 34 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	72974-120-04	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	72974-120-04	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	72974-120-04	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	72974-120-04	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	72974-120-04	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	72974-120-04	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	72974-120-04	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	72974-120-04	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	72974-120-04	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	72974-120-04	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	72974-120-04	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	72974-120-04	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	72974-120-04	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	72974-120-04	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	72974-120-04	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	72974-120-04	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	72974-120-04	`8fc7167e32ce…`	`e96bbc724034…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N214621-001	ORGOVYX	RELUGOLIX	120MG	TABLET / ORAL		RLD, RS	2020-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214621-001	8058280	2026-01-28		Drug substance, Drug product	2021-01-14
N214621-001	7300935	2029-01-28		Drug substance	2021-01-14
N214621-001	11795178	2033-09-27		Drug substance, Drug product	2023-10-25
N214621-001	12325714	2033-09-27		Drug substance, Drug product	2025-06-11
N214621-001	10350170	2036-02-25		Drug product	2021-01-14
N214621-001	10449191	2037-09-29	U-3020		2021-01-14
N214621-001	10786501	2037-09-29	U-3020		2021-01-14
N214621-001	11583526	2037-09-29	U-3020		2023-03-16
N214621-001	12097198	2037-09-29	U-3020		2024-09-25
N214621-001	12144809	2037-09-29	U-4035		2024-11-21
N214621-001	12336990	2037-09-29	U-3020		2025-06-25
N214621-001	12629370	2037-09-29	U-3020		2026-06-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 297 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214621-001	8058280	2026-01-28		Drug substance, Drug product	2021-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	7300935	2029-01-28		Drug substance	2021-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	11795178	2033-09-27		Drug substance, Drug product	2023-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	12325714	2033-09-27		Drug substance, Drug product	2025-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	10350170	2036-02-25		Drug product	2021-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	10449191	2037-09-29	U-3020		2021-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	10786501	2037-09-29	U-3020		2021-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	11583526	2037-09-29	U-3020		2023-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	12097198	2037-09-29	U-3020		2024-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	12144809	2037-09-29	U-4035		2024-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	12336990	2037-09-29	U-3020		2025-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214621-001	12629370	2037-09-29	U-3020		2026-06-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214621-001	8058280	2026-01-28		Drug substance, Drug product	2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	7300935	2029-01-28		Drug substance	2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	11795178	2033-09-27		Drug substance, Drug product	2023-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	12325714	2033-09-27		Drug substance, Drug product	2025-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	10350170	2036-02-25		Drug product	2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	10449191	2037-09-29	U-3020		2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	10786501	2037-09-29	U-3020		2021-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	11583526	2037-09-29	U-3020		2023-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	12097198	2037-09-29	U-3020		2024-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	12144809	2037-09-29	U-4035		2024-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	12336990	2037-09-29	U-3020		2025-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214621-001	12629370	2037-09-29	U-3020		2026-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214621-001	8058280	2026-01-28		Drug substance, Drug product	2021-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	7300935	2029-01-28		Drug substance	2021-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	11795178	2033-09-27		Drug substance, Drug product	2023-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	12325714	2033-09-27		Drug substance, Drug product	2025-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	10350170	2036-02-25		Drug product	2021-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	10449191	2037-09-29	U-3020		2021-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	10786501	2037-09-29	U-3020		2021-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	11583526	2037-09-29	U-3020		2023-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	12097198	2037-09-29	U-3020		2024-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	12144809	2037-09-29	U-4035		2024-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214621-001	12336990	2037-09-29	U-3020		2025-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214621-001	8058280	2026-01-28		Drug substance, Drug product	2021-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214621-001	7300935	2029-01-28		Drug substance	2021-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214621-001	11795178	2033-09-27		Drug substance, Drug product	2023-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214621-001	12325714	2033-09-27		Drug substance, Drug product	2025-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214621-001	10350170	2036-02-25		Drug product	2021-01-14	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214621-001	NCE	2025-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214621-001	NCE	2025-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214621-001	NCE	2025-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214621-001	NCE	2025-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214621-001	NCE	2025-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214621-001	NCE	2025-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214621-001	NCE	2025-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214621-001	NCE	2025-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214621-001	NCE	2025-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214621-001	NCE	2025-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214621-001	NCE	2025-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214621-001	NCE	2025-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214621-001	NCE	2025-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214621-001	NCE	2025-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214621-001	NCE	2025-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214621-001	NCE	2025-12-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214621-001	NCE	2025-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214621-001	NCE	2025-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214621-001	NCE	2025-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214621-001	NCE	2025-12-18	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214621-001	NCE	2025-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214621-001	NCE	2025-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214621-001	NCE	2025-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214621-001	NCE	2025-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214621-001	NCE	2025-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214621-001	NCE	2025-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214621-001	NCE	2025-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214621-001	NCE	2025-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214621-001	NCE	2025-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214621-001	NCE	2025-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214621-001	NCE	2025-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214621-001	NCE	2025-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214621-001	NCE	2025-12-18	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RELUGOLIX	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P76B05O5V6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2472783	Internal RxNorm lookup
2472789	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
077a92f6-9f1b-479a-87c7-c92b5db6aa9c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c4d424e-6243-4523-bf62-cb9f42ba3b2b	Product name	1	20210609
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72974-120-01	Orgovyx	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	12
72974-120-95	Orgovyx	16 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	16	12
72974-120-97	Orgovyx	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72974-120-01	EA - Each	72974-120	426afb74-e064-4164-8c78-a11a8ab39264	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72974-120	ORGOVYX (RELUGOLIX) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.]	11	Current NDC, Legacy NDC, 3 package rows	20241031_077a92f6-9f1b-479a-87c7-c92b5db6aa9c.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
Orgovyx	RELUGOLIX	Sumitomo Pharma America, Inc.	077a92f6-9f1b-479a-87c7-c92b5db6aa9c	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214621 application number: NDA214621 ndc (product): 72974-120

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P76B05O5V6	RELUGOLIX	737789-87-6	RELUGOLIX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2472789	ORGOVYX 120 MG Oral Tablet	PSN	077a92f6-9f1b-479a-87c7-c92b5db6aa9c	12
2472783	relugolix 120 MG Oral Tablet	PSN	077a92f6-9f1b-479a-87c7-c92b5db6aa9c	12
2472789	relugolix 120 MG Oral Tablet [Orgovyx]	SBD	077a92f6-9f1b-479a-87c7-c92b5db6aa9c	12
2472783	relugolix 120 MG Oral Tablet	SCD	077a92f6-9f1b-479a-87c7-c92b5db6aa9c	12
2472789	Orgovyx 120 MG Oral Tablet	SY	077a92f6-9f1b-479a-87c7-c92b5db6aa9c	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72974-120-01	72974012001	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01)	2020-12-18	0000-00-00	No	No	Current
72974-120-95	72974012095	16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95)	2023-01-27		Yes	No	Current
72974-120-97	72974012097	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97)	2021-10-21	0000-00-00	Yes	No	Current