Application 212304
- Type
- NDA
- Sponsor
- CORIUM, INC.
Application Products#
| 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 |
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | ADLARITY | 5MG/DAY | SYSTEM / TRANSDERMAL | RLD | 2022-03-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | ADLARITY | 10MG/DAY | SYSTEM / TRANSDERMAL | RLD | 2022-03-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | ADLARITY | 5MG/DAY | SYSTEM / TRANSDERMAL | RLD | 2022-03-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-002 | ADLARITY | 10MG/DAY | SYSTEM / TRANSDERMAL | RLD | 2022-03-11 | caaa826d4ba7… | |
| 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… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 12161767 | 2036-12-30 | U-3334 | Drug substance, Drug product | 2025-01-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 12168075 | 2036-12-30 | U-3334 | 2025-01-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 11679086 | 2037-05-26 | U-3334 | 2023-07-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 10016372 | 2037-07-26 | U-3334 | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 10300025 | 2037-07-26 | Drug product | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 10307379 | 2037-07-26 | Drug product | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 11103463 | 2037-07-26 | U-3334 | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 9993466 | 2037-07-26 | Drug product | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 11648214 | 2037-09-23 | U-3334 | Drug product | 2023-06-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 10835499 | 2038-05-20 | U-3334 | Drug product | 2022-04-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212304-001 | 10966936 | 2038-08-11 | U-3334 | Drug product | 2022-04-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 12161767 | 2036-12-30 | U-3334 | Drug substance, Drug product | 2025-01-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 12168075 | 2036-12-30 | U-3334 | 2025-01-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 11679086 | 2037-05-26 | U-3334 | 2023-07-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 10016372 | 2037-07-26 | U-3334 | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 10300025 | 2037-07-26 | Drug product | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 10307379 | 2037-07-26 | Drug product | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 11103463 | 2037-07-26 | U-3334 | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 9993466 | 2037-07-26 | Drug product | 2022-04-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 11648214 | 2037-09-23 | U-3334 | Drug product | 2023-06-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 10835499 | 2038-05-20 | U-3334 | Drug product | 2022-04-06 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N212304-002 | 10966936 | 2038-08-11 | U-3334 | Drug product | 2022-04-06 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 12161767 | 2036-12-30 | U-3334 | Drug substance, Drug product | 2025-01-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 12168075 | 2036-12-30 | U-3334 | 2025-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 11679086 | 2037-05-26 | U-3334 | 2023-07-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 10016372 | 2037-07-26 | U-3334 | 2022-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 10300025 | 2037-07-26 | Drug product | 2022-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 10307379 | 2037-07-26 | Drug product | 2022-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 11103463 | 2037-07-26 | U-3334 | 2022-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 9993466 | 2037-07-26 | Drug product | 2022-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 11648214 | 2037-09-23 | U-3334 | Drug product | 2023-06-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 10835499 | 2038-05-20 | U-3334 | Drug product | 2022-04-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212304-001 | 10966936 | 2038-08-11 | U-3334 | Drug product | 2022-04-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212304-002 | 12161767 | 2036-12-30 | U-3334 | Drug substance, Drug product | 2025-01-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212304-002 | 12168075 | 2036-12-30 | U-3334 | 2025-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-002 | 11679086 | 2037-05-26 | U-3334 | 2023-07-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-002 | 10016372 | 2037-07-26 | U-3334 | 2022-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-002 | 10300025 | 2037-07-26 | Drug product | 2022-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-002 | 10307379 | 2037-07-26 | Drug product | 2022-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212304-002 | 11103463 | 2037-07-26 | U-3334 | 2022-04-06 | caaa826d4ba7… |
Observed Orange Book exclusivity history#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | e2ab403a-ec2d-44e7-9da1-66d0a7443f1d | 2025-06-05 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil hydrochloride | DONEPEZIL HYDROCHLORIDE | Dr. Reddys Laboratories Limited | 7c0d3bcb-157d-0414-64ee-055bc614d190 | 2025-04-11 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Coupler LLC | 2d01fb96-c825-fad5-e063-6394a90ac6cc | 2025-01-31 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | Direct_Rx | 93dddf28-094b-dd8c-e053-2995a90a63e9 | 2025-01-22 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | DirectRx | cb1b3ed1-6e68-08e2-e053-2995a90a68c4 | 2025-01-20 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 7620f41a-3eef-453b-a564-ea3c85374de2 | 2025-01-08 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil | DONEPEZIL HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 11ac01f4-d26e-47b2-9660-d514ab097fdb | 2025-01-07 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE | Lupin Pharmaceuticals, Inc. | 03e26183-3e07-45e8-a414-a8bad32483e2 | 2024-11-29 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | ac857917-74db-4591-be9f-d1c822c68c81 | 2024-07-18 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | c030fd7c-da5c-457a-a825-1767bd87d04d | 2024-04-03 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | 4747633b-ac32-455e-8d50-ce9c481480c0 | 2024-04-03 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | aa2c22b8-2dd4-4916-bc4f-9995eab74a6e | 2024-04-03 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | 1c6e8d7f-5219-4b6c-a1ce-2baff28c3d55 | 2024-02-06 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | 8090bff0-e0f0-4846-a2ab-cb28a0a2648d | 2024-02-05 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | caebc31c-5a35-4434-b7e2-80f6405383ca | 2024-01-11 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Aurobindo Pharma Limited | 3257494f-8f44-4978-b92d-bde87b2444b6 | 2024-01-08 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 86b0c5a0-ff3c-4840-a4ac-82af922d58bf | 2024-01-08 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| donepezil hydrochloride | DONEPEZIL HYDROCHLORIDE | Bryant Ranch Prepack | c26d9bf3-e148-48bb-8f4f-e8c73804b311 | 2023-11-17 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| Donepezil Hydrochloride | DONEPEZIL HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 06dd25a5-1bf2-446d-ad75-ff9d55117660 | 2023-08-11 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
| donepezil hydrochloride | DONEPEZIL HYDROCHLORIDE | A-S Medication Solutions | 5d46ef3c-0dee-4389-a2d5-997ea8342817 | 2023-02-06 | Warnings, Adverse reactions | DONEPEZIL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |