Home NDC 43547-382-50 donepezil hydrochloride
Product NDC 43547-382
Requested package NDC 43547-382-50
11-digit product format 435470382
Labeler code 43547
Product ID 43547-382_0de518b0-75a0-466f-9e20-15c2e00aefbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Solco Healthcare US, LLC
Application ANDA203713
Marketing category ANDA
Marketing start 2016-12-05
Marketing end 0000-00-00
Substance DONEPEZIL HYDROCHLORIDE
Active strength 23 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 1 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43547-382 43547-382-50 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A203713-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203713-001 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 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 43547-382-03 2020-03-05 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 43547-382-09 2020-03-05 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 43547-382-10 2020-03-05 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 43547-382-50 2020-03-05 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 43547-382-03 2020-01-31 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 43547-382-09 2020-01-31 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 43547-382-10 2020-01-31 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 43547-382-50 2020-01-31 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-382 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC] 2 Legacy NDC 20200305_64c81ee1-aee6-4f44-b048-c301d0304ff5.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43547-382-50 43547038250 500 TABLET, FILM COATED in 1 BOTTLE (43547-382-50) 2016-12-05 0000-00-00 No No Current