Home NDC 62856-245 Aricept
Product NDC 62856-245
11-digit product format 628560245
Labeler code 62856
Product ID 62856-245_4bc1cba0-8ebe-4b11-b4a4-19148d4249c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Eisai Inc.
Application NDA020690
Marketing category NDA
Marketing start 1996-11-25
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 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
Additional Listing Data#
Finished product Yes
Brand name base Aricept
Listing expiration 2027-12-31 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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997220 Internal RxNorm lookup 997222 Internal RxNorm lookup 997223 Internal RxNorm lookup 997224 Internal RxNorm lookup 997226 Internal RxNorm lookup 997228 Internal RxNorm lookup 997229 Internal RxNorm lookup 997230 Internal RxNorm lookup 1100184 Internal RxNorm lookup 1100187 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 62856-245-11 Aricept 1000 in 1 BOTTLE TABLET, FILM COATED 1000 31 62856-245-30 Aricept 30 in 1 BOTTLE TABLET, FILM COATED 30 31 62856-245-41 Aricept 10 in 1 CARTON TABLET, FILM COATED 10 31 62856-245-41 Aricept 10 in 1 BLISTER PACK TABLET, FILM COATED 10 31 62856-245-90 Aricept 90 in 1 BOTTLE TABLET, FILM COATED 90 31
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 ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 DONEPEZIL ACTIVE MOIETY 8SSC91326P ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 TALC INACTIVE INGREDIENT 7SEV7J4R1U ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 16 DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 DONEPEZIL ACTIVE MOIETY 8SSC91326P ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62856-245 ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.] 31 Current NDC, Legacy NDC, 5 package rows 20231118_98e451e1-e4d7-4439-a675-c5457ba20975.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 62856-245-11 62856024511 1000 in 1 BOTTLE Historical 62856-245-30 62856024530 30 TABLET, FILM COATED in 1 BOTTLE (62856-245-30) 1996-11-25 0000-00-00 No No Current 62856-245-41 62856024541 10 in 1 CARTON Historical 62856-245-90 62856024590 90 in 1 BOTTLE Historical