Home NDC 68788-8711 Donepezil Hydrochloride
Product NDC 68788-8711
11-digit product format 687888711
Labeler code 68788
Product ID 68788-8711_c9fdb857-2048-40fe-a3d1-4e89dda6cdf4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA078662
Marketing category ANDA
Marketing start 2024-07-08
Substance DONEPEZIL HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078662-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 A078662-002 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 · 86 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 2026-09-14 22:38:34 2026-08 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078662-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078662-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Donepezil Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DONEPEZIL HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3O2T2PJ89D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997229 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-8711-3 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET 30 3 68788-8711-6 Donepezil Hydrochloride 60 in 1 BOTTLE TABLET 60 3 68788-8711-9 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8711 DONEPEZIL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 3 package rows 20250406_ee54a472-6783-41df-b8bb-9c3e4c996907.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8711-3 68788871103 30 TABLET in 1 BOTTLE (68788-8711-3) 30 tablet 2024-07-08 No No Current 68788-8711-6 68788871106 60 TABLET in 1 BOTTLE (68788-8711-6) 60 tablet 2024-07-08 No No Current 68788-8711-9 68788871109 90 TABLET in 1 BOTTLE (68788-8711-9) 90 tablet 2024-07-08 No No Current