Home NDC 29300-248 donepezil hydrochloride
Product NDC 29300-248
11-digit product format 293000248
Labeler code 29300
Product ID 29300-248_88d3f867-45f4-42fb-93f8-235c2f594760
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA203656
Marketing category ANDA
Marketing start 2016-06-23
Substance DONEPEZIL HYDROCHLORIDE
Active strength 5 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203656-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 A203656-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23
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 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2016-06-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2016-06-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203656-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2016-06-23 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203656-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2016-06-23 782e0a99824c…
Observed Orange Book normalized TE history# 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 5 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997220 Internal RxNorm lookup 997223 Internal RxNorm lookup 997226 Internal RxNorm lookup 997229 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 29300-248-01 donepezil hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 12 29300-248-10 donepezil hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 12 29300-248-13 donepezil hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 12 29300-248-19 donepezil hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-248 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [UNICHEM PHARMACEUTICALS (USA), INC.] 11 Current NDC, Legacy NDC, 4 package rows 20201204_1a8906ce-96dc-4bc8-81c1-5db67a187aac.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 Marketing end Sample Exclude flag Status 29300-248-01 29300024801 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-01) 2018-02-28 0000-00-00 No No Current 29300-248-10 29300024810 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-10) 2018-02-28 0000-00-00 No No Current 29300-248-13 29300024813 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-13) 2018-02-28 0000-00-00 No No Current 29300-248-19 29300024819 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-248-19) 2018-02-28 0000-00-00 No No Current