Home NDC 55289-151-21 Aricept
Product NDC 55289-151
Requested package NDC 55289-151-21
11-digit product format 552890151
Labeler code 55289
Product ID 55289-151_dd0401d5-c524-7684-e053-2995a90aafbe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020690
Marketing category NDA
Marketing start 1996-11-25
Marketing end 0000-00-00
Substance DONEPEZIL HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 DONEPEZIL ACTIVE MOIETY 8SSC91326P ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aricept DONEPEZIL HYDROCHLORIDE Eisai Inc. 98e451e1-e4d7-4439-a675-c5457ba20975 2021-12-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 020690 application number: NDA020690
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-151-21 55289015121 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-151-21) 2010-11-03 0000-00-00 No No Current