Home NDC 24979-004 Donepezil Hydrochloride
Product NDC 24979-004
11-digit product format 249790004
Labeler code 24979
Product ID 24979-004_e1f7708c-55a7-4201-86c6-089ff0cce422
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA203104
Marketing category ANDA
Marketing start 2015-03-01
Substance DONEPEZIL HYDROCHLORIDE
Active strength 23 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203104-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203104-001 AB
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 · 41 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 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203104-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-10-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 23 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 1100184 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 24979-004-03 2023-02-01 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-03 2023-02-01 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-06 2023-02-01 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-06 2023-02-01 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-07 2023-02-01 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-07 2023-02-01 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-03 2023-01-30 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-03 2023-01-30 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-06 2023-01-30 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-06 2023-01-30 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-07 2023-01-30 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, for ORAL use. Initial U.S. Approval: 1996 24979-004-07 2023-01-30 Donepezil Hydrochloride Tablets These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABELTS safely and effectively. see full prescribing information for DONEPEZIL HYDROCHLORIDE TABELTS. Donepezil Hydrochloride (donepezil hydrochloride) TABLET, 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 24979-004-03 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 22 24979-004-06 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 22 24979-004-07 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 HYPROMELLOSE 2208 (4000 MPA.S) INACTIVE INGREDIENT 39J80LT57T DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [TWI PHARMACEUTICALS, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24979-004 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] 22 Current NDC, Legacy NDC, 3 package rows 20250410_12a755c5-1ad9-43d1-832a-eb2ff17bd693.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 · 5 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 24979-004-03 24979000403 1000 in 1 BOTTLE Historical 24979-004-06 24979000406 30 TABLET, FILM COATED in 1 BOTTLE (24979-004-06) 2015-03-01 0000-00-00 No No Current 24979-004-07 24979000407 90 TABLET, FILM COATED in 1 BOTTLE (24979-004-07) 2015-09-22 0000-00-00 No No Current