EXXUA

Product NDC: 23594-152
11-digit product format: 235940152
Labeler code: 23594
Product ID: 23594-152_414d62f1-85aa-cfa6-e063-6394a90a69fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: gepirone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aytu Therapeutics, LLC
Application: NDA021164
Marketing category: NDA
Marketing start: 2025-10-01
Substance: GEPIRONE HYDROCHLORIDE
Active strength: 54.5 mg/1
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021164-001	EXXUA	GEPIRONE HYDROCHLORIDE	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-09-22
N021164-002	EXXUA	GEPIRONE HYDROCHLORIDE	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22
N021164-003	EXXUA	GEPIRONE HYDROCHLORIDE	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22
N021164-004	EXXUA	GEPIRONE HYDROCHLORIDE	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-09-22

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N021164-001	7538116	2030-09-02	U-3699	2023-10-18
N021164-002	7538116	2030-09-02	U-3699	2023-10-18
N021164-003	7538116	2030-09-02	U-3699	2023-10-18
N021164-004	7538116	2030-09-02	U-3699	2023-10-18

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N021164-001	NCE	2028-09-22
N021164-002	NCE	2028-09-22
N021164-003	NCE	2028-09-22
N021164-004	NCE	2028-09-22

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-001	EXXUA	EQ 18.2MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-002	EXXUA	EQ 36.3MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-003	EXXUA	EQ 54.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-004	EXXUA	EQ 72.6MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-09-22	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021164-001	7538116	2030-09-02	U-3699	2023-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-002	7538116	2030-09-02	U-3699	2023-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-003	7538116	2030-09-02	U-3699	2023-10-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-004	7538116	2030-09-02	U-3699	2023-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021164-001	7538116	2030-09-02	U-3699	2023-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-002	7538116	2030-09-02	U-3699	2023-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-003	7538116	2030-09-02	U-3699	2023-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-004	7538116	2030-09-02	U-3699	2023-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-001	7538116	2030-09-02	U-3699	2023-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-002	7538116	2030-09-02	U-3699	2023-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-003	7538116	2030-09-02	U-3699	2023-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-004	7538116	2030-09-02	U-3699	2023-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021164-001	7538116	2025-09-02	U-3699	2023-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-002	7538116	2025-09-02	U-3699	2023-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-003	7538116	2025-09-02	U-3699	2023-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-004	7538116	2025-09-02	U-3699	2023-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-001	7538116	2025-09-02	U-3699	2023-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-002	7538116	2025-09-02	U-3699	2023-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-003	7538116	2025-09-02	U-3699	2023-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-004	7538116	2025-09-02	U-3699	2023-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-001	7538116	2025-09-02	U-3699	2023-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-002	7538116	2025-09-02	U-3699	2023-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-003	7538116	2025-09-02	U-3699	2023-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-004	7538116	2025-09-02	U-3699	2023-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-001	7538116	2025-09-02	U-3699	2023-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-002	7538116	2025-09-02	U-3699	2023-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-003	7538116	2025-09-02	U-3699	2023-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-004	7538116	2025-09-02	U-3699	2023-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-001	7538116	2025-09-02	U-3699	2023-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-002	7538116	2025-09-02	U-3699	2023-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-003	7538116	2025-09-02	U-3699	2023-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-004	7538116	2025-09-02	U-3699	2023-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-001	7538116	2025-09-02	U-3699	2023-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-002	7538116	2025-09-02	U-3699	2023-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-003	7538116	2025-09-02	U-3699	2023-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-004	7538116	2025-09-02	U-3699	2023-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-001	7538116	2025-09-02	U-3699	2023-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-002	7538116	2025-09-02	U-3699	2023-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-003	7538116	2025-09-02	U-3699	2023-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-004	7538116	2025-09-02	U-3699	2023-10-18	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N021164-001	NCE	2028-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-002	NCE	2028-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-003	NCE	2028-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021164-004	NCE	2028-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021164-001	NCE	2028-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-002	NCE	2028-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-003	NCE	2028-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021164-004	NCE	2028-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-001	NCE	2028-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-002	NCE	2028-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-003	NCE	2028-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021164-004	NCE	2028-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021164-001	NCE	2028-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-002	NCE	2028-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-003	NCE	2028-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021164-004	NCE	2028-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-001	NCE	2028-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-002	NCE	2028-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-003	NCE	2028-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021164-004	NCE	2028-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-001	NCE	2028-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-002	NCE	2028-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-003	NCE	2028-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021164-004	NCE	2028-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-001	NCE	2028-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-002	NCE	2028-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-003	NCE	2028-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021164-004	NCE	2028-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-001	NCE	2028-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-002	NCE	2028-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-003	NCE	2028-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021164-004	NCE	2028-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-001	NCE	2028-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-002	NCE	2028-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-003	NCE	2028-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021164-004	NCE	2028-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-001	NCE	2028-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-002	NCE	2028-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-003	NCE	2028-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021164-004	NCE	2028-09-22	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: EXXUA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GEPIRONE HYDROCHLORIDE	54.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
80C9L8EP6V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2672372	Internal RxNorm lookup
2672379	Internal RxNorm lookup
2672382	Internal RxNorm lookup
2672385	Internal RxNorm lookup
2672388	Internal RxNorm lookup
2672391	Internal RxNorm lookup
2672394	Internal RxNorm lookup
2672397	Internal RxNorm lookup
2732202	Internal RxNorm lookup
2732203	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
0c78edd8-6acb-433c-9d34-2527da8d64e1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6f638e74-cd6e-451d-887a-7ed2461179ec	Product name	1	20231013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
23594-152-30	EXXUA	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23594-152-30	EA - Each	23594-152	79e55f47-55c4-4d64-a099-2a4d26fd54f3	1	2025-11-13

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
EXXUA	GEPIRONE	Aytu Therapeutics, LLC	0c78edd8-6acb-433c-9d34-2527da8d64e1	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021164 application number: NDA021164 ndc (product): 23594-152

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
80C9L8EP6V	GEPIRONE HYDROCHLORIDE	83928-66-9	GEPIRONE HYDROCHLORIDE
JW5Y7B8Z18	GEPIRONE	83928-76-1	gepirone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2732203	{32 (24 HR gepirone 18.2 MG Extended Release Oral Tablet [Exxua]) } Pack [Exxua Titration Pack]	BPCK	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2732202	{32 (24 HR gepirone 18.2 MG Extended Release Oral Tablet) } Pack	GPCK	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672379	EXXUA 18.2 MG 24HR Extended Release Oral Tablet	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672385	EXXUA 36.3 MG 24HR Extended Release Oral Tablet	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672391	EXXUA 54.5 MG 24HR Extended Release Oral Tablet	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672397	EXXUA 72.6 MG 24HR Extended Release Oral Tablet	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2732203	exxua Titration Pack	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672372	gepirone 18.2 MG 24HR Extended Release Oral Tablet	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2732202	gepirone 18.2 MG 24HR Extended Release Oral Tablet (32) Titration Pack	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672382	gepirone 36.3 MG 24HR Extended Release Oral Tablet	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672388	gepirone 54.5 MG 24 HR Extended Release Oral Tablet	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672394	gepirone 72.6 MG 24 HR Extended Release Oral Tablet	PSN	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672379	24 HR gepirone 18.2 MG Extended Release Oral Tablet [Exxua]	SBD	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672385	24 HR gepirone 36.3 MG Extended Release Oral Tablet [Exxua]	SBD	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672391	24 HR gepirone 54.5 MG Extended Release Oral Tablet [Exxua]	SBD	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672397	24 HR gepirone 72.6 MG Extended Release Oral Tablet [Exxua]	SBD	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672372	24 HR gepirone 18.2 MG Extended Release Oral Tablet	SCD	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672382	24 HR gepirone 36.3 MG Extended Release Oral Tablet	SCD	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672388	24 HR gepirone 54.5 MG Extended Release Oral Tablet	SCD	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672394	24 HR gepirone 72.6 MG Extended Release Oral Tablet	SCD	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672379	24 HR Exxua 18.2 MG Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672385	24 HR Exxua 36.3 MG Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672391	24 HR Exxua 54.5 MG Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672397	24 HR Exxua 72.6 MG Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672379	Exxua 18.2 MG (equivalent to 20 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672385	Exxua 36.3 MG (equivalent to 40 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672391	Exxua 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672397	Exxua 72.6 MG (equivalent to 80 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2732203	Exxua Titration Pack	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672372	gepirone 18.2 MG (equivalent to 20 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2732202	gepirone 18.2 MG 24 HR Extended Release Oral Tablet Titration Pack, 32 Tablets	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672382	gepirone 36.3 MG (equivalent to 40 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672388	gepirone 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2
2672394	gepirone 72.6 MG (equivalent to 80 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet	SY	0c78edd8-6acb-433c-9d34-2527da8d64e1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
23594-152-30	23594015230	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-152-30)	2025-10-01	No	No	Current