Home NDC 55648-312 Donepezil Hydrochloride
Product NDC 55648-312
11-digit product format 556480312
Labeler code 55648
Product ID 55648-312_63aed8fa-52e1-4e47-91ed-cb7fd6b8cce0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt Limited
Application ANDA091267
Marketing category ANDA
Marketing start 2011-05-28
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 4 · 189 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 A091267-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 A091267-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31
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 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091267-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL 2011-05-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091267-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL 2011-05-31 782e0a99824c…
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 A091267-001 AB 1 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A091267-002 AB 1 ea99ee380514…
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 55648-312-01 Donepezil Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 2 55648-312-02 Donepezil Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 2 55648-312-03 Donepezil Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 2 55648-312-04 Donepezil Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 2 55648-312-05 Donepezil Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2 55648-312-06 Donepezil Hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 55648-312-06 Donepezil Hydrochloride 100 in 1 CARTON TABLET, FILM COATED 100 2 55648-312-07 Donepezil Hydrochloride 28 in 1 BOTTLE TABLET, FILM COATED 28 2 55648-312-08 Donepezil Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 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 [WOCKHARDT LIMITED] 2 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-312 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 Legacy NDC, 9 package rows 20130611_b7c926f0-8771-41d7-95be-3d4110dc0603.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 55648-312-01 55648031201 30 in 1 BOTTLE Historical 55648-312-02 55648031202 60 in 1 BOTTLE Historical 55648-312-03 55648031203 90 in 1 BOTTLE Historical 55648-312-04 55648031204 500 in 1 BOTTLE Historical 55648-312-05 55648031205 1000 in 1 BOTTLE Historical 55648-312-06 55648031206 1 in 1 BLISTER PACK Historical 55648-312-07 55648031207 28 in 1 BOTTLE Historical 55648-312-08 55648031208 100 in 1 BOTTLE Historical