Home NDC 64239-404 Donepezil Hydrochloride
Product NDC 64239-404
11-digit product format 642390404
Labeler code 64239
Product ID 64239-404_4881001c-c215-2033-e054-00144ff8d46c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dexcel Pharma Technologies Ltd.
Application ANDA203713
Marketing category ANDA
Marketing start 2016-07-01
Marketing end 0000-00-00
Substance DONEPEZIL HYDROCHLORIDE
Active strength 23 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203713-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2016-02-19 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 A203713-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203713-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203713-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64239-404-03 Donepezil Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 6 64239-404-10 Donepezil Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 6 64239-404-50 Donepezil Hydrochloride 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64239-404 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DEXCEL PHARMA TECHNOLOGIES LTD.] 6 Legacy NDC, 3 package rows 20170214_04498589-1cbb-4008-80ce-f9f1ac57eb86.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 Status 64239-404-03 64239040403 30 in 1 BOTTLE, PLASTIC Historical 64239-404-10 64239040410 100 in 1 BOTTLE, PLASTIC Historical 64239-404-50 64239040450 500 in 1 BOTTLE, PLASTIC Historical