Oriahnn

Product NDC: 0074-1017
11-digit product format: 000741017
Labeler code: 0074
Product ID: 0074-1017_92a6192f-7a2b-4bb7-be46-4664e07dcf44
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Elagolix and Estradiol and Norethisterone
Dosage form: KIT
Labeler: AbbVie Inc.
Application: NDA213388
Marketing category: NDA
Marketing start: 2020-05-29
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

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
N213388-001	ORIAHNN (COPACKAGED)	ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL		RLD, RS	2020-05-29

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02
N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29
N213388-001	10881659	2034-03-14	U-2842		2021-02-03
N213388-001	11045470	2034-03-14	U-2842		2021-07-27
N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08
N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06
N213388-001	11690845	2040-08-27	U-3655		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.

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	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213388-001	ORIAHNN (COPACKAGED)	EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	CAPSULE / ORAL	RLD, RS	2020-05-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 228 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	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213388-001	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	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	12083227	2038-08-20	U-2842	Drug product	2024-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	11542239	2039-07-23		Drug substance, Drug product	2023-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213388-001	11690845	2040-08-27	U-3655		2023-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	7056927	2024-09-10		Drug substance, Drug product	2020-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	11459305	2028-11-07	U-2842	Drug product	2022-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	7419983	2029-07-06		Drug substance, Drug product	2020-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	10881659	2034-03-14	U-2842		2021-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213388-001	11045470	2034-03-14	U-2842		2021-07-27	`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	N213388-001	NP	2023-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213388-001	NCE	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213388-001	NP	2023-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213388-001	NCE	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213388-001	NP	2023-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213388-001	NCE	2023-07-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213388-001	NP	2023-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213388-001	NCE	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213388-001	NP	2023-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213388-001	NCE	2023-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213388-001	NP	2023-05-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213388-001	NCE	2023-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213388-001	NP	2023-05-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N213388-001	NCE	2023-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213388-001	NP	2023-05-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213388-001	NCE	2023-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213388-001	NP	2023-05-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N213388-001	NCE	2023-07-23	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N213388-001	NP	2023-05-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213388-001	NCE	2023-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213388-001	NP	2023-05-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213388-001	NCE	2023-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213388-001	NP	2023-05-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213388-001	NCE	2023-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213388-001	NP	2023-05-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213388-001	NCE	2023-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213388-001	NP	2023-05-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213388-001	NCE	2023-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213388-001	NP	2023-05-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213388-001	NCE	2023-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213388-001	NP	2023-05-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213388-001	NCE	2023-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213388-001	NP	2023-05-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213388-001	NCE	2023-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213388-001	NP	2023-05-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213388-001	NCE	2023-07-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213388-001	NP	2023-05-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N213388-001	NCE	2023-07-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213388-001	NP	2023-05-29	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213388-001	NCE	2023-07-23	`cb3db0bc1861…`

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2371764	Internal RxNorm lookup
2371766	Internal RxNorm lookup
2371767	Internal RxNorm lookup
2371768	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
99f6eee7-7e52-6999-7eb8-488d06dd1710	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379	Product name	2	20250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6	Product name	2	20250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1	Product name	6	20250311
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbf	Product name	2	20250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1	Product name	3	20240507
66263a7f-f64d-41c4-90f1-2cee106617cc	Product name	1	20240501
859c4b0b-8cba-4f41-9afe-cc181a01fb62	Product name	2	20240215
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94	Product name	3	20220126
0a040ba8-1f34-4328-bb07-4f64503daaab	Product name	2	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
c21bcd2e-ecbd-48e6-ab68-12cc12256c0f	Product name	2	20190213
84ef4224-f07c-4c4b-8889-3ae70f4b627d	Product name	1	20181003
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
3f090665-4687-4bb4-8790-8efb1930ee74	Product name	1	20180801
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
f6ac5560-6d3b-d281-41d2-adc50d283c20	Product name	3	20170228
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
7a549f52-8b99-472c-8b1d-3a70c53c9bf4	Product name	1	20160623
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
3ca8d96e-517a-05ea-5690-f8e1d3726540	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0074-1017-14	Oriahnn	1 in 1 BLISTER PACK	KIT	1	41
0074-1017-14	Oriahnn	1 in 1 CARTON	KIT	1	41
0074-1017-56	Oriahnn	4 in 1 CARTON	KIT	4	41
0074-1017-56	Oriahnn	1 in 1 BLISTER PACK	KIT	1	41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0074-1017-56	EA - Each	0074-1017	dbe28f74-c173-4a8d-b552-32322994837a	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0074-1017	ORIAHNN (ELAGOLIX AND ESTRADIOL AND NORETHISTERONE) KIT [ABBVIE INC.]	38	Current NDC, Legacy NDC, 4 package rows	20241004_99f6eee7-7e52-6999-7eb8-488d06dd1710.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
Oriahnn	ELAGOLIX AND ESTRADIOL AND NORETHISTERONE	AbbVie Inc.	99f6eee7-7e52-6999-7eb8-488d06dd1710	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213388 application number: NDA213388 ndc (product): 0074-1017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2371768	{28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } Pack [Oriahnn 28 Day Kit]	BPCK	99f6eee7-7e52-6999-7eb8-488d06dd1710	41
2371767	{28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } Pack	GPCK	99f6eee7-7e52-6999-7eb8-488d06dd1710	41
2371764	elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule	PSN	99f6eee7-7e52-6999-7eb8-488d06dd1710	41
2371766	elagolix 300 MG Oral Capsule	PSN	99f6eee7-7e52-6999-7eb8-488d06dd1710	41
2371768	Oriahnn 28 Day Kit	PSN	99f6eee7-7e52-6999-7eb8-488d06dd1710	41
2371764	elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule	SCD	99f6eee7-7e52-6999-7eb8-488d06dd1710	41
2371766	elagolix 300 MG Oral Capsule	SCD	99f6eee7-7e52-6999-7eb8-488d06dd1710	41
2371767	(elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG (28) Oral Capsule) / (elagolix 300 MG (28) Oral Capsule) Pack	SY	99f6eee7-7e52-6999-7eb8-488d06dd1710	41
2371768	Oriahnn 28 Day Kit	SY	99f6eee7-7e52-6999-7eb8-488d06dd1710	41

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0074-1017-14	00074101714	1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK	1 blister pack	2020-09-24	0000-00-00	Yes	No	Current
0074-1017-56	00074101756	4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK	4 blister pack	2020-05-29	0000-00-00	No	No	Current