Home NDC 33342-061 Donepezil Hydrochloride
Product NDC 33342-061
11-digit product format 333420061
Labeler code 33342
Product ID 33342-061_4bf742a3-3c8f-4bd3-b973-54370cbef345
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA202631
Marketing category ANDA
Marketing start 2014-01-23
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 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A202631-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202631-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202631-001 DONEPEZIL HYDROCHLORIDE 23MG TABLET / ORAL AB 2014-01-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 5 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 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 33342-061-07 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 16 33342-061-10 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 16 33342-061-12 Donepezil Hydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 16 33342-061-12 Donepezil Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 16 33342-061-07 Donepezil hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 2 33342-061-10 Donepezil hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 2 33342-061-12 Donepezil hydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 2 33342-061-12 Donepezil hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2
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 [MACLEODS PHARMACEUTICALS LIMITED] 9 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 9 DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-061 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 16 Current NDC, Legacy NDC, 4 package rows 20230817_06dd25a5-1bf2-446d-ad75-ff9d55117660.zip 33342-061 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 2 Current NDC, Legacy NDC, 4 package rows 20150901_ecddf11f-5784-4576-a7e6-1b3560c4d2ea.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 Units Marketing start Marketing end Sample Exclude flag Status 33342-061-07 33342006107 30 TABLET, FILM COATED in 1 BOTTLE (33342-061-07) 2014-01-23 0000-00-00 No No Current 33342-061-10 33342006110 90 TABLET, FILM COATED in 1 BOTTLE (33342-061-10) 2014-01-23 0000-00-00 No No Current 33342-061-12 33342006112 10 BLISTER PACK in 1 CARTON (33342-061-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2014-01-23 0000-00-00 No No Current