Home Applications 020690 Application 020690
Type NDA
Sponsor EISAI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARICEPT DONEPEZIL HYDROCHLORIDE TABLET;ORAL 10MG Yes Yes 002 ARICEPT DONEPEZIL HYDROCHLORIDE TABLET;ORAL 5MG Yes No
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 N020690-001 ARICEPT DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB RLD, RS 1996-11-25 N020690-002 ARICEPT DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB RLD 1996-11-25
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 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020690-001 ARICEPT 10MG TABLET / ORAL AB RLD, RS 1996-11-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020690-002 ARICEPT 5MG TABLET / ORAL AB RLD 1996-11-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 25 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-7623 donepezil hydrochloride DONEPEZIL HYDROCHLORIDE NCS HealthCare of KY, Inc dba Vangard Labs NDA Current 0615-7624 donepezil hydrochloride DONEPEZIL HYDROCHLORIDE NCS HealthCare of KY, Inc dba Vangard Labs NDA Current 55289-151 Aricept donepezil hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-151 Aricept donepezil hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-151 Aricept donepezil hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-151 Aricept donepezil hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-151 Aricept donepezil hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 62856-245 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-245 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-245 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-245 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-245 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-245 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-245 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-245 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-246 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-246 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-246 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-246 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-246 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-246 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-246 Aricept donepezil hydrochloride Eisai Inc. NDA Current 62856-246 Aricept donepezil hydrochloride Eisai Inc. NDA Current 67046-128 Donepezil Hydrochloride Donepezil Hydrochloride Contract Pharmacy Services-PA NDA Current 67046-129 Donepezil Hydrochloride Donepezil Hydrochloride Contract Pharmacy Services-PA NDA Current