Orgovyx

Product NDC: 72974-120
11-digit product format: 729740120
Labeler code: 72974
Product ID: 72974-120_3090b0d4-bc5f-4d32-91d9-bf63a0ce3a84
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: 2027-12-31
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 45.

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
2026-11-14 07:37:17	2026-10	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N214621-001	ORGOVYX	120MG	TABLET / ORAL	RLD, RS	2020-12-18	`c2088c7a36db…`
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 9 · 321 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-11-14 07:37:17	2026-10	N214621-001	8058280	2026-01-28		Drug substance, Drug product	2021-01-14	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	7300935	2029-01-28		Drug substance	2021-01-14	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	11795178	2033-09-27		Drug substance, Drug product	2023-10-25	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	12325714	2033-09-27		Drug substance, Drug product	2025-06-11	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	10350170	2036-02-25		Drug product	2021-01-14	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	10449191	2037-09-29	U-3020		2021-01-14	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	10786501	2037-09-29	U-3020		2021-01-14	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	11583526	2037-09-29	U-3020		2023-03-16	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	12097198	2037-09-29	U-3020		2024-09-25	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	12144809	2037-09-29	U-4035		2024-11-21	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	12336990	2037-09-29	U-3020		2025-06-25	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N214621-001	12629370	2037-09-29	U-3020		2026-06-09	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N214621-001	8058280	2026-01-28		Drug substance, Drug product	2021-01-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	7300935	2029-01-28		Drug substance	2021-01-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	11795178	2033-09-27		Drug substance, Drug product	2023-10-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	12325714	2033-09-27		Drug substance, Drug product	2025-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	10350170	2036-02-25		Drug product	2021-01-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	10449191	2037-09-29	U-3020		2021-01-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	10786501	2037-09-29	U-3020		2021-01-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	11583526	2037-09-29	U-3020		2023-03-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	12097198	2037-09-29	U-3020		2024-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	12144809	2037-09-29	U-4035		2024-11-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	12336990	2037-09-29	U-3020		2025-06-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214621-001	12629370	2037-09-29	U-3020		2026-06-09	`c2088c7a36db…`
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…`

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: 2027-12-31

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

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