Home NDC 50090-2627 Donepezil
Product NDC 50090-2627
11-digit product format 500902627
Labeler code 50090
Product ID 50090-2627_1eda014d-ec3c-4940-a6a2-3dfe24b07712
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA203034
Marketing category ANDA
Marketing start 2015-02-02
Substance DONEPEZIL HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203034-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 A203034-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203034-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203034-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-01-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Donepezil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DONEPEZIL HYDROCHLORIDE 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997223 Internal RxNorm lookup 997229 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-2627-0 Donepezil 90 in 1 BOTTLE TABLET 90 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2627 DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS] 24 Current NDC, Legacy NDC, 1 package rows 20230208_84d8ca68-26f3-4dd5-9dd4-6a7525a30db1.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 Units Marketing start Marketing end Sample Exclude flag Status 50090-2627-0 50090262700 90 TABLET in 1 BOTTLE (50090-2627-0) 90 tablet 2016-11-17 0000-00-00 No No Current