Home NDC 42799-954 Donepezil hydrochloride
Product NDC 42799-954
11-digit product format 427990954
Labeler code 42799
Product ID 42799-954_19147d81-49ac-463e-8643-26dace803ea5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Edenbridge Pharmaceuticals LLC.
Application ANDA203713
Marketing category ANDA
Marketing start 2016-02-19
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 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.
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42799-954-01 Donepezil hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 2 42799-954-02 Donepezil hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42799-954 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [EDENBRIDGE PHARMACEUTICALS LLC.] 1 Current NDC, 2 package rows 20231208_11404dc3-1bde-4d4e-8386-006b67ee19dd.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 Marketing start Sample Exclude flag Status 42799-954-01 42799095401 30 TABLET, FILM COATED in 1 BOTTLE (42799-954-01) 2023-12-05 No No Current 42799-954-02 42799095402 90 TABLET, FILM COATED in 1 BOTTLE (42799-954-02) 2023-12-05 No No Current