Home NDC 62756-194 Donepezil Hydrochloride
Product NDC 62756-194
11-digit product format 627560194
Labeler code 62756
Product ID 62756-194_65890f83-ea1b-4342-b403-6ebe155bc357
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA204293
Marketing category ANDA
Marketing start 2015-06-17
Substance DONEPEZIL HYDROCHLORIDE
Active strength 23 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204293-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05
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 2 · 41 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 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2015-06-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204293-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL 2015-06-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A204293-001 AB 1 ea99ee380514…
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 23 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997223 Internal RxNorm lookup 997229 Internal RxNorm lookup 1100184 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 62756-194-18 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8 62756-194-81 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 8 62756-194-83 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-194 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 Current NDC, Legacy NDC, 3 package rows 20181031_79ad107b-bb20-4ed3-89f0-d7c862f3957c.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 62756-194-18 62756019418 1000 TABLET, FILM COATED in 1 BOTTLE (62756-194-18) 2015-06-17 0000-00-00 No No Current 62756-194-81 62756019481 90 TABLET, FILM COATED in 1 BOTTLE (62756-194-81) 2015-06-17 0000-00-00 No No Current 62756-194-83 62756019483 30 TABLET, FILM COATED in 1 BOTTLE (62756-194-83) 2015-06-17 0000-00-00 No No Current