Home NDC 65038-055-01 Adlarity
Product NDC 65038-055
Requested package NDC 65038-055-01
11-digit product format 650380055
Labeler code 65038
Product ID 65038-055_9697bb6c-5a73-4bb9-8792-271fdf733c5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form PATCH
Route TRANSDERMAL
Labeler Corium, Inc.
Application NDA212304
Marketing category NDA
Marketing start 2022-03-11
Marketing end 0000-00-00
Substance DONEPEZIL HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 Product TE source text 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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65038-055 ADLARITY (DONEPEZIL HYDROCHLORIDE) PATCH [CORIUM, LLC.] 3 Legacy NDC 20230219_1cb44c65-00e8-4b5c-99c2-ad15173115a0.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65038-055-01 65038005501 1 PATCH in 1 POUCH (65038-055-01) 1 patch 2022-09-07 0000-00-00 No No Current