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

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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-312IInactivated by FDA2026-08-03
excluded packagepackage55648-31255648-312-01IInactivated by FDA2026-08-03
excluded packagepackage55648-31255648-312-02IInactivated by FDA2026-08-03
excluded packagepackage55648-31255648-312-03IInactivated by FDA2026-08-03
excluded packagepackage55648-31255648-312-04IInactivated by FDA2026-08-03
excluded packagepackage55648-31255648-312-05IInactivated by FDA2026-08-03
excluded packagepackage55648-31255648-312-06IInactivated by FDA2026-08-03
excluded packagepackage55648-31255648-312-07IInactivated by FDA2026-08-03
excluded packagepackage55648-31255648-312-08IInactivated by FDA2026-08-03

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.

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 packagepackage55648-312-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-312-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-312-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-312-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-312-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-312-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-312-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-312-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-312-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-312-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-312-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-312-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-312-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-312-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-312-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-312-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-312-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-312-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-312-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-312-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-312-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-312-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-312-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-312-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-312-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-312-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-312-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-312-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-312-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-312-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-312-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-312-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-312-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-312-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-312-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-312-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-312-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-312-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-312-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-312-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-312-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-312-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-312-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-312-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-312-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-312-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-312-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-312-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-312-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-312-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-312-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-312-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-312-08302b2466d912…e7b80fea0513…

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
A091267-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31
A091267-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091267-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORAL2011-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A091267-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORAL2011-05-31782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A091267-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091267-002AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
55648-312-01These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: 1996
55648-312-02These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: 1996
55648-312-03These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: 1996
55648-312-04These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: 1996
55648-312-05These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: 1996
55648-312-06These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: 1996
55648-312-07These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: 1996
55648-312-08These highlights do not include all the information needed to use donepezil hydrochloride tablets safely and effectively. See full prescribing information for donepezil hydrochloride tablets. Donepezil Hydrochloride Tablets Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-312-01Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
55648-312-02Donepezil Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
55648-312-03Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902
55648-312-04Donepezil Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
55648-312-05Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10002
55648-312-06Donepezil Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
55648-312-06Donepezil Hydrochloride100 in 1 CARTONTABLET, FILM COATED1002
55648-312-07Donepezil Hydrochloride28 in 1 BOTTLETABLET, FILM COATED282
55648-312-08Donepezil Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-312DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 9 package rows20130611_b7c926f0-8771-41d7-95be-3d4110dc0603.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSNb7c926f0-8771-41d7-95be-3d4110dc06032
997229donepezil HCl 5 MG Oral TabletPSNb7c926f0-8771-41d7-95be-3d4110dc06032
997223donepezil hydrochloride 10 MG Oral TabletSCDb7c926f0-8771-41d7-95be-3d4110dc06032
997229donepezil hydrochloride 5 MG Oral TabletSCDb7c926f0-8771-41d7-95be-3d4110dc06032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-312-015564803120130 in 1 BOTTLEHistorical
55648-312-025564803120260 in 1 BOTTLEHistorical
55648-312-035564803120390 in 1 BOTTLEHistorical
55648-312-0455648031204500 in 1 BOTTLEHistorical
55648-312-05556480312051000 in 1 BOTTLEHistorical
55648-312-06556480312061 in 1 BLISTER PACKHistorical
55648-312-075564803120728 in 1 BOTTLEHistorical
55648-312-0855648031208100 in 1 BOTTLEHistorical