Home NDC 42254-305 DONEPEZIL HYDROCHLORIDE
Product NDC 42254-305
11-digit product format 422540305
Labeler code 42254
Product ID 42254-305_09b48fda-460a-496b-8644-db205465d06c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DONEPEZIL HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA091267
Marketing category ANDA
Marketing start 2011-05-28
Marketing end 0000-00-00
Substance DONEPEZIL HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42254-305-90 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42254-305-90 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42254-305-90 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42254-305-90 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42254-305-90 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42254-305-90 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42254-305-90 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42254-305-90 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42254-305-90 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42254-305-90 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42254-305-90 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42254-305-90 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 42254-305-90 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 42254-305-90 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 42254-305-90 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 42254-305-90 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 42254-305-90 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 42254-305-90 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 42254-305-90 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 42254-305-90 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 42254-305-90 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 42254-305-90 110d247fa046…a55b01930146…
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 A091267-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 A091267-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31
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 · 82 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 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 782e0a99824c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A091267-001 AB 1 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A091267-002 AB 1 ea99ee380514…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42254-305-90 DONEPEZIL HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42254-305 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 1 package rows 20130221_09b48fda-460a-496b-8644-db205465d06c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 42254-305-90 42254030590 90 in 1 BOTTLE Historical