Home NDC 46708-295 Donepezil Hydrochloride
Product NDC 46708-295
11-digit product format 467080295
Labeler code 46708
Product ID 46708-295_f0627628-81b1-4b14-b49d-1e68b350146f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA201724
Marketing category ANDA
Marketing start 2016-01-29
Substance DONEPEZIL HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 A201724-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 A201724-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Donepezil Hydrochloride
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997223 Internal RxNorm lookup 997229 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 46708-295-10 2023-02-01 These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 46708-295-30 2023-02-01 These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 46708-295-90 2023-02-01 These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 46708-295-91 2023-02-01 These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 46708-295-10 2023-01-30 These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 46708-295-30 2023-01-30 These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 46708-295-90 2023-01-30 These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996 46708-295-91 2023-01-30 These highlights do not include all the information needed to use donepezil hydrochloride safely and effectively. See full prescribing information for donepezil hydrochloride tablets. DONEPEZIL hydrochloride tablets, for oral use Initial U.S. Approval: 1996
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-295-10 Donepezil Hydrochloride 100 in 1 CARTON TABLET, FILM COATED 100 3 46708-295-30 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 3 46708-295-90 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 3 46708-295-91 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-295 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20230202_bc570682-413b-46fb-a069-c2986884bfce.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 46708-295-10 46708029510 100 TABLET, FILM COATED in 1 CARTON (46708-295-10) 2016-01-29 0000-00-00 No No Current 46708-295-30 46708029530 30 TABLET, FILM COATED in 1 BOTTLE (46708-295-30) 2016-01-29 0000-00-00 No No Current 46708-295-90 46708029590 90 TABLET, FILM COATED in 1 BOTTLE (46708-295-90) 2016-01-29 0000-00-00 No No Current 46708-295-91 46708029591 1000 TABLET, FILM COATED in 1 BOTTLE (46708-295-91) 2016-01-29 0000-00-00 No No Current