Home NDC 55111-357-05 Donepezil hydrochloride
Product NDC 55111-357
Requested package NDC 55111-357-05
11-digit product format 551110357
Labeler code 55111
Product ID 55111-357_d6af4584-b379-0cea-78b6-a493f88708c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Donepezil hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddys Laboratories Limited
Application ANDA201001
Marketing category ANDA
Marketing start 2011-05-31
Substance DONEPEZIL HYDROCHLORIDE
Active strength 10 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201001-001 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 A201001-002 DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31
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 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201001-001 DONEPEZIL HYDROCHLORIDE 5MG TABLET / ORAL AB 2011-05-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201001-002 DONEPEZIL HYDROCHLORIDE 10MG TABLET / ORAL AB 2011-05-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55111-357-05 Donepezil hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 11 55111-357-10 Donepezil hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 11 55111-357-30 Donepezil hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 11 55111-357-78 Donepezil hydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 11 55111-357-79 Donepezil hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 11 55111-357-90 Donepezil hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 11
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 [DR. REDDYS LABORATORIES LIMITED] 7 Donepezil ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 7 DONEPEZIL HYDROCHLORIDE ACTIVE INGREDIENT 3O2T2PJ89D DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 DONEPEZIL ACTIVE MOIETY 8SSC91326P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-357 DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED] 11 Current NDC, Legacy NDC, 6 package rows 20241222_4c9889fd-2cb3-02da-f034-46120acc38c3.zip
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 55111-357-05 55111035705 500 TABLET, FILM COATED in 1 BOTTLE (55111-357-05) 2011-05-31 0000-00-00 No No Current