Donepezil Hydrochloride

Product NDC
0781-5276
11-digit product format
007815276
Labeler code
0781
Product ID
0781-5276_ba3b76a0-19e3-4b09-abef-bdcf3649a127
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA091198
Marketing category
ANDA
Marketing start
2011-05-10
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-5276DDiscontinued by firm2026-08-10
excluded packagepackage0781-52760781-5276-01DDiscontinued by firm2026-08-10
excluded packagepackage0781-52760781-5276-10DDiscontinued by firm2026-08-10
excluded packagepackage0781-52760781-5276-31DDiscontinued by firm2026-08-10
excluded packagepackage0781-52760781-5276-64DDiscontinued by firm2026-08-10

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 · 58 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5276-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5276-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5276-64d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5276-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5276-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5276-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5276-64f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5276-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5276-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5276-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5276-642ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5276-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5276-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5276-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5276-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5276-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5276-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5276-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5276-64cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5276-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5276-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5276-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5276-64cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5276-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5276-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5276-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5276-64302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5276-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5276-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5276-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5276-64ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5276-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5276-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5276-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5276-640efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5276-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5276-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5276-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5276-64ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5276-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5276-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5276-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5276-64367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5276-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5276-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5276-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5276-10557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091198-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10
A091198-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORAL2011-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALABRS2011-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALABRS2011-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALABRS2011-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALABRS2011-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-05-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALABRS2011-05-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091198-001DONEPEZIL HYDROCHLORIDE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-05-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A091198-002DONEPEZIL HYDROCHLORIDE10MGTABLET, ORALLY DISINTEGRATING / ORALABRS2011-05-10782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091198-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091198-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091198-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091198-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091198-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091198-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091198-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091198-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091198-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091198-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091198-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091198-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091198-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091198-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091198-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091198-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091198-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091198-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091198-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091198-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091198-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091198-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091198-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091198-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091198-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091198-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091198-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091198-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091198-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A091198-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091198-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A091198-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091198-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091198-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091198-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091198-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091198-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091198-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091198-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091198-002AB13f0d92c62455…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5276-64EA - Each0781-527699685f86-850c-452f-8a6d-f5effa8baeba12012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5276-640078152766430 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5276-64) 2011-05-100000-00-00NoNoCurrent