Application 212304

Type: NDA
Sponsor: CORIUM, INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADLARITY	DONEPEZIL HYDROCHLORIDE	SYSTEM;TRANSDERMAL	5MG/24HR	No	No
002	ADLARITY	DONEPEZIL HYDROCHLORIDE	SYSTEM;TRANSDERMAL	10MG/24HR	No	No

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
N212304-001	ADLARITY	DONEPEZIL HYDROCHLORIDE	5MG/DAY	SYSTEM / TRANSDERMAL		RLD	2022-03-11
N212304-002	ADLARITY	DONEPEZIL HYDROCHLORIDE	10MG/DAY	SYSTEM / TRANSDERMAL		RLD	2022-03-11

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212304-001	12161767	2036-12-30	U-3334	Drug substance, Drug product	2025-01-10
N212304-001	12168075	2036-12-30	U-3334		2025-01-10
N212304-001	11679086	2037-05-26	U-3334		2023-07-03
N212304-001	10016372	2037-07-26	U-3334		2022-04-06
N212304-001	10300025	2037-07-26		Drug product	2022-04-06
N212304-001	10307379	2037-07-26		Drug product	2022-04-06
N212304-001	11103463	2037-07-26	U-3334		2022-04-06
N212304-001	9993466	2037-07-26		Drug product	2022-04-06
N212304-001	11648214	2037-09-23	U-3334	Drug product	2023-06-02
N212304-001	10835499	2038-05-20	U-3334	Drug product	2022-04-06
N212304-001	10966936	2038-08-11	U-3334	Drug product	2022-04-06
N212304-002	12161767	2036-12-30	U-3334	Drug substance, Drug product	2025-01-10
N212304-002	12168075	2036-12-30	U-3334		2025-01-10
N212304-002	11679086	2037-05-26	U-3334		2023-07-03
N212304-002	10016372	2037-07-26	U-3334		2022-04-06
N212304-002	10300025	2037-07-26		Drug product	2022-04-06
N212304-002	10307379	2037-07-26		Drug product	2022-04-06
N212304-002	11103463	2037-07-26	U-3334		2022-04-06
N212304-002	9993466	2037-07-26		Drug product	2022-04-06
N212304-002	11648214	2037-09-23	U-3334	Drug product	2023-06-02
N212304-002	10835499	2038-05-20	U-3334	Drug product	2022-04-06
N212304-002	10966936	2038-08-11	U-3334	Drug product	2022-04-06

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 2 · 60 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	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212304-001	ADLARITY	5MG/DAY	SYSTEM / TRANSDERMAL	RLD	2022-03-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212304-002	ADLARITY	10MG/DAY	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-11	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 530 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	N212304-001	12161767	2036-12-30	U-3334	Drug substance, Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	12168075	2036-12-30	U-3334		2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	11679086	2037-05-26	U-3334		2023-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	10016372	2037-07-26	U-3334		2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	10300025	2037-07-26		Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	10307379	2037-07-26		Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	11103463	2037-07-26	U-3334		2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	9993466	2037-07-26		Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	11648214	2037-09-23	U-3334	Drug product	2023-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	10835499	2038-05-20	U-3334	Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-001	10966936	2038-08-11	U-3334	Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	12161767	2036-12-30	U-3334	Drug substance, Drug product	2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	12168075	2036-12-30	U-3334		2025-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	11679086	2037-05-26	U-3334		2023-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	10016372	2037-07-26	U-3334		2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	10300025	2037-07-26		Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	10307379	2037-07-26		Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	11103463	2037-07-26	U-3334		2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	9993466	2037-07-26		Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	11648214	2037-09-23	U-3334	Drug product	2023-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	10835499	2038-05-20	U-3334	Drug product	2022-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212304-002	10966936	2038-08-11	U-3334	Drug product	2022-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	12161767	2036-12-30	U-3334	Drug substance, Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	12168075	2036-12-30	U-3334		2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	11679086	2037-05-26	U-3334		2023-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	10016372	2037-07-26	U-3334		2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	10300025	2037-07-26		Drug product	2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	10307379	2037-07-26		Drug product	2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	11103463	2037-07-26	U-3334		2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	9993466	2037-07-26		Drug product	2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	11648214	2037-09-23	U-3334	Drug product	2023-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	10835499	2038-05-20	U-3334	Drug product	2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-001	10966936	2038-08-11	U-3334	Drug product	2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	12161767	2036-12-30	U-3334	Drug substance, Drug product	2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	12168075	2036-12-30	U-3334		2025-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	11679086	2037-05-26	U-3334		2023-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	10016372	2037-07-26	U-3334		2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	10300025	2037-07-26		Drug product	2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	10307379	2037-07-26		Drug product	2022-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	11103463	2037-07-26	U-3334		2022-04-06	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

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	N212304-001	NP	2025-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212304-002	NP	2025-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212304-001	NP	2025-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212304-002	NP	2025-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212304-001	NP	2025-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212304-002	NP	2025-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212304-001	NP	2025-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212304-002	NP	2025-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212304-001	NP	2025-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212304-002	NP	2025-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212304-001	NP	2025-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212304-002	NP	2025-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212304-001	NP	2025-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212304-002	NP	2025-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212304-001	NP	2025-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212304-002	NP	2025-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212304-001	NP	2025-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212304-002	NP	2025-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212304-001	NP	2025-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212304-002	NP	2025-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212304-001	NP	2025-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212304-002	NP	2025-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212304-001	NP	2025-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212304-002	NP	2025-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212304-001	NP	2025-03-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212304-002	NP	2025-03-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212304-001	NP	2025-03-11	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212304-002	NP	2025-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212304-001	NP	2025-03-11	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N212304-002	NP	2025-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212304-001	NP	2025-03-11	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N212304-002	NP	2025-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212304-001	NP	2025-03-11	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212304-002	NP	2025-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212304-001	NP	2025-03-11	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212304-002	NP	2025-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212304-001	NP	2025-03-11	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212304-002	NP	2025-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212304-001	NP	2025-03-11	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212304-002	NP	2025-03-11	`3f0d92c62455…`

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 3 · 52 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	a085ed33-c262-44ab-e053-2a95a90a5557	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	12a755c5-1ad9-43d1-832a-eb2ff17bd693	2026-05-08	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Cardinal Health 107, LLC	c942a4c9-dbe5-4131-bb6c-aa2d31b387e7	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ee54a472-6783-41df-b8bb-9c3e4c996907	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8138f616-83f3-4c47-84ef-1bce2db339f7	2026-04-08	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	41c095b6-acd9-4627-a813-bbca7ecafee5	2026-03-30	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	56abe961-ec94-4a77-b548-426f6255539e	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Major Pharmaceuticals	c777ddc9-0b61-4d6f-95d6-818ba1861d62	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Torrent Pharmaceuticals Limited	76bf638e-dbde-418e-8977-1caf009990bc	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	6e9aacf9-abb6-4dec-9a8d-4eabf934d512	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	A-S Medication Solutions	84d8ca68-26f3-4dd5-9dd4-6a7525a30db1	2026-01-20	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	1a8906ce-96dc-4bc8-81c1-5db67a187aac	2025-12-19	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	c7e1f642-1bdc-4ed6-9b9e-c1af40b926cd	2025-12-05	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	American Health Packaging	12ae85f0-023c-49ca-8c4a-0a6a7585290e	2025-09-24	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	11404dc3-1bde-4d4e-8386-006b67ee19dd	2025-08-01	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	de96349a-5fee-4de9-921c-e453d44b3203	2025-07-16	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil	DONEPEZIL HYDROCHLORIDE	REMEDYREPACK INC.	37fc6638-4a63-4582-a64c-3525f8ed7ef2	2025-07-02	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Solco Healthcare US, LLC	48178cb4-4fee-47c0-88e9-a4f017f1f448	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride	DONEPEZIL HYDROCHLORIDE	Solco Healthcare US, LLC	042a59ea-131a-4806-b0f4-2f791d4414e2	2025-06-30	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride	DONEPEZIL HYDROCHLORIDE	Bryant Ranch Prepack	e2ab403a-ec2d-44e7-9da1-66d0a7443f1d	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: DONEPEZIL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65038-055	Adlarity	Donepezil Hydrochloride	Corium, Inc.	NDA	Current
65038-055	Adlarity	Donepezil Hydrochloride	Corium, Inc.	NDA	Current
65038-056	Adlarity	Donepezil Hydrochloride	Corium, Inc.	NDA	Current
65038-056	Adlarity	Donepezil Hydrochloride	Corium, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72665	ORIG	2022-11-22
70521	ORIG	2022-03-15
70510	ORIG	2022-03-14