Home NDC 55111-302-10 Donepezil hydrochloride
Product NDC 55111-302
Requested package NDC 55111-302-10
11-digit product format 551110302
Labeler code 55111
Product ID 55111-302_0df6bfb2-4604-2035-9677-06c125e77bb9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddys Laboratories Limited
Application ANDA202723
Marketing category ANDA
Marketing start 2025-08-20
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55111-302 55111-302-10 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55111-302 55111-302-10 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55111-302 55111-302-10 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A202723-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202723-001 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 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202723-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2013-07-24 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 2026-12-31 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 55111-302-05 2025-03-04 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 55111-302-10 2025-03-04 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 55111-302-30 2025-03-04 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 55111-302-90 2025-03-04 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 55111-302-05 2025-01-30 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 55111-302-10 2025-01-30 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 55111-302-30 2025-01-30 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996 55111-302-90 2025-01-30 These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS 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 55111-302-30 Donepezil hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 10 55111-302-90 Donepezil hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 10
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 [DR. REDDYS LABORATORIES LIMITED] 3 Donepezil ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) INACTIVE INGREDIENT 74G4R6TH13 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 3
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 Marketing start Marketing end Sample Exclude flag Status 55111-302-10 55111030210 1000 TABLET, FILM COATED in 1 BOTTLE (55111-302-10) 2013-07-26 0000-00-00 No No Current