Home NDC 46708-093 Donepezil Hydrochloride
Product NDC 46708-093
11-digit product format 467080093
Labeler code 46708
Product ID 46708-093_6ca3acff-fe7c-483a-a728-39e06c279dbb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA201724
Marketing category ANDA
Marketing start 2013-02-19
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 2019-12-31
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 2 · 84 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 A201724-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 A201724-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25
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 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201724-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2013-02-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201724-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2013-02-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-093-10 Donepezil Hydrochloride5 mg 100 in 1 CARTON TABLET, FILM COATED 100 1 46708-093-30 Donepezil Hydrochloride5 mg 30 in 1 BOTTLE TABLET, FILM COATED 30 1 46708-093-91 Donepezil Hydrochloride5 mg 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-093 DONEPEZIL HYDROCHLORIDE 5 MG (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] 1 Legacy NDC, 3 package rows 20140610_6ca3acff-fe7c-483a-a728-39e06c279dbb.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 46708-093-10 46708009310 100 in 1 CARTON Historical 46708-093-30 46708009330 30 in 1 BOTTLE Historical 46708-093-91 46708009391 1000 in 1 BOTTLE Historical