Orilissa

Product NDC: 0074-0038
11-digit product format: 000740038
Labeler code: 0074
Product ID: 0074-0038_12b19eff-edfe-4218-96b3-f2446c6f2a6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Elagolix
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AbbVie Inc.
Application: NDA210450
Marketing category: NDA
Marketing start: 2018-07-23
Substance: ELAGOLIX SODIUM
Active strength: 150 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0074-0038	0074-0038-01	D	Discontinued by firm		2026-08-07

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210450-001	ORILISSA	ELAGOLIX SODIUM	EQ 150MG BASE	TABLET / ORAL		RLD	2018-07-23
N210450-002	ORILISSA	ELAGOLIX SODIUM	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2018-07-23

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210450-001	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20
N210450-001	11707464	2034-03-14	U-3672		2023-08-23
N210450-001	10537572	2036-09-01	U-2735		2020-02-19
N210450-001	10682351	2036-09-01	U-2850		2020-07-15
N210450-001	11690854	2038-04-19	U-3653		2023-08-02
N210450-001	12102637	2038-08-20		Drug product	2024-10-29
N210450-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06
N210450-001	11690845	2040-08-27	U-3654		2023-08-02
N210450-002	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20
N210450-002	11344551	2034-03-14	U-3388		2022-06-27
N210450-002	11344551	2034-03-14	U-3389		2022-06-27
N210450-002	12102637	2038-08-20		Drug product	2024-10-29
N210450-002	11542239	2039-07-23		Drug substance, Drug product	2023-02-06
N210450-002	11690845	2040-08-27	U-3654		2023-08-02

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210450-001	ORILISSA	EQ 150MG BASE	TABLET / ORAL	RLD	2018-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210450-002	ORILISSA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2018-07-23	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 550 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210450-001	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	11707464	2034-03-14	U-3672		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	10537572	2036-09-01	U-2735		2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	10682351	2036-09-01	U-2850		2020-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	11690854	2038-04-19	U-3653		2023-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	12102637	2038-08-20		Drug product	2024-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-001	11690845	2040-08-27	U-3654		2023-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	11344551	2034-03-14	U-3388		2022-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	11344551	2034-03-14	U-3389		2022-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	12102637	2038-08-20		Drug product	2024-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210450-002	11690845	2040-08-27	U-3654		2023-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	11707464	2034-03-14	U-3672		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	10537572	2036-09-01	U-2735		2020-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	10682351	2036-09-01	U-2850		2020-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	11690854	2038-04-19	U-3653		2023-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	12102637	2038-08-20		Drug product	2024-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-001	11690845	2040-08-27	U-3654		2023-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	11344551	2034-03-14	U-3388		2022-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	11344551	2034-03-14	U-3389		2022-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	12102637	2038-08-20		Drug product	2024-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210450-002	11690845	2040-08-27	U-3654		2023-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210450-001	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	11707464	2034-03-14	U-3672		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	10537572	2036-09-01	U-2735		2020-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	10682351	2036-09-01	U-2850		2020-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	11690854	2038-04-19	U-3653		2023-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	12102637	2038-08-20		Drug product	2024-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-001	11690845	2040-08-27	U-3654		2023-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	7419983	2029-07-06	U-2360	Drug substance, Drug product	2018-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	11344551	2034-03-14	U-3388		2022-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	11344551	2034-03-14	U-3389		2022-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210450-002	12102637	2038-08-20		Drug product	2024-10-29	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

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	N210450-001	NCE	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210450-002	NCE	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210450-001	NCE	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210450-002	NCE	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210450-001	NCE	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210450-002	NCE	2023-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210450-001	NCE	2023-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210450-002	NCE	2023-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210450-001	NCE	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210450-002	NCE	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210450-001	NCE	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210450-002	NCE	2023-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210450-001	NCE	2023-07-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210450-002	NCE	2023-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210450-001	NCE	2023-07-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210450-002	NCE	2023-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210450-001	NCE	2023-07-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210450-002	NCE	2023-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210450-001	NCE	2023-07-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210450-002	NCE	2023-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210450-001	NCE	2023-07-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210450-002	NCE	2023-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210450-001	NCE	2023-07-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N210450-002	NCE	2023-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210450-001	NCE	2023-07-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N210450-002	NCE	2023-07-23	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N210450-001	NCE	2023-07-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N210450-002	NCE	2023-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210450-001	NCE	2023-07-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210450-002	NCE	2023-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210450-001	NCE	2023-07-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210450-002	NCE	2023-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210450-001	NCE	2023-07-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210450-002	NCE	2023-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210450-001	NCE	2023-07-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210450-002	NCE	2023-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210450-001	NCE	2023-07-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N210450-002	NCE	2023-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210450-001	NCE	2023-07-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N210450-002	NCE	2023-07-23	`3bdfa0b2c4d7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ELAGOLIX SODIUM	150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5948VUI423	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2049852	Internal RxNorm lookup
2049858	Internal RxNorm lookup
2049860	Internal RxNorm lookup
2049862	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
a86757b3-09c5-fd3b-1223-244e94f50a66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
84ef4224-f07c-4c4b-8889-3ae70f4b627d	Product name	1	20181003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0074-0038-01	Orilissa	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	111
0074-0038-01	Orilissa	1 in 1 CARTON	TABLET, FILM COATED	1	111
0074-0038-07	Orilissa	1 in 1 CARTON	TABLET, FILM COATED	1	111
0074-0038-07	Orilissa	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	111
0074-0038-28	Orilissa	7 in 1 BLISTER PACK	TABLET, FILM COATED	7	111
0074-0038-28	Orilissa	4 in 1 CARTON	TABLET, FILM COATED	4	111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-0038-28	EA - Each	0074-0038	dfab128c-9de3-4ef5-bca5-c4d04bc72627	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-0038	ORILISSA (ELAGOLIX) TABLET, FILM COATED [ABBVIE INC.]	108	Current NDC, Legacy NDC, 6 package rows	20241013_a86757b3-09c5-fd3b-1223-244e94f50a66.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
Orilissa	ELAGOLIX	AbbVie Inc.	a86757b3-09c5-fd3b-1223-244e94f50a66	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210450 application number: NDA210450 ndc (product): 0074-0038

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5948VUI423	ELAGOLIX SODIUM	832720-36-2	ELAGOLIX SODIUM
5B2546MB5Z	ELAGOLIX	834153-87-6	Elagolix

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2049852	elagolix 150 MG Oral Tablet	PSN	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049860	elagolix 200 MG Oral Tablet	PSN	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049858	Orilissa 150 MG Oral Tablet	PSN	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049862	Orilissa 200 MG Oral Tablet	PSN	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049858	elagolix 150 MG Oral Tablet [Orilissa]	SBD	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049862	elagolix 200 MG Oral Tablet [Orilissa]	SBD	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049852	elagolix 150 MG Oral Tablet	SCD	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049860	elagolix 200 MG Oral Tablet	SCD	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049852	elagolix 150 MG (as elagolix sodium 155.2 MG) Oral Tablet	SY	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049860	elagolix 200 MG (as egalolix sodium 207 MG) Oral Tablet	SY	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049858	Orilissa 150 MG Oral Tablet	SY	a86757b3-09c5-fd3b-1223-244e94f50a66	111
2049862	Orilissa 200 MG Oral Tablet	SY	a86757b3-09c5-fd3b-1223-244e94f50a66	111

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-0038-01	00074003801	1 BLISTER PACK in 1 CARTON (0074-0038-01) > 7 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2018-07-23	0000-00-00	No	No	Current
0074-0038-07	00074003807	1 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2018-07-23	0000-00-00	Yes	No	Current
0074-0038-28	00074003828	4 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	2018-07-23	0000-00-00	No	No	Current