DONEPEZIL HYDROCHLORIDE

Product NDC
72189-031
Requested package NDC
72189-031-60
11-digit product format
721890031
Labeler code
72189
Product ID
72189-031_2c4e974d-41bb-49ca-e063-6394a90ae3a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DONEPEZIL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA200292
Marketing category
ANDA
Marketing start
2019-10-01
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72189-03172189-031-60IInactivated by FDA2026-09-14

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A200292-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31
A200292-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A200292-001AB
A200292-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3184e616aacf4f…
2026-09-14 22:38:342026-08A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3184e616aacf4f…
2026-08-18 06:07:402026-07A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3174a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A200292-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A200292-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A200292-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200292-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200292-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200292-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200292-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200292-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200292-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200292-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200292-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200292-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200292-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200292-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200292-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200292-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200292-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200292-002AB174a2ff9319b5…

Additional Listing Data#

Finished product
Yes
Brand name base
DONEPEZIL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3O2T2PJ89DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
997229Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93dddf28-094b-dd8c-e053-2995a90a63e9Available on FDA.report

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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-031-602025-01-30C16284748780-12cef2736-90eb-d83d-e063-dadaa90ab31fDONEPEZIL HYDROCHLORIDE
72189-031-902025-01-30C16284748780-12cef2736-5ed6-d83d-e063-dadaa90ab31fDONEPEZIL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-031-30DONEPEZIL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED303
72189-031-60DONEPEZIL HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED601
72189-031-90DONEPEZIL HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-031-30EA - Each72189-031747ad637-10cc-4a13-90ac-6c2a3e72c7cc12019-10-07
72189-031-60EA - Each72189-031fb2f9b26-8c7a-4faf-ad19-b0e7ff6a68bf12019-10-07
72189-031-90EA - Each72189-031300cebe4-2ccf-4a72-848d-48a1b16e513312019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-031DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]3Current NDC, Legacy NDC, 1 package rows20250123_93dddf28-094b-dd8c-e053-2995a90a63e9.zip
72189-031DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20191002_93dd96a4-3a74-ea7e-e053-2a95a90ab0a4.zip
72189-031DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20191002_92fce88e-9fdf-43a8-e053-2995a90a5867.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.41c095b6-acd9-4627-a813-bbca7ecafee52026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC48178cb4-4fee-47c0-88e9-a4f017f1f4482025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC042a59ea-131a-4806-b0f4-2f791d4414e22025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_Rx93dddf28-094b-dd8c-e053-2995a90a63e92025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 72189-031
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirectRxcb1b3ed1-6e68-08e2-e053-2995a90a68c42025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackc26d9bf3-e148-48bb-8f4f-e8c73804b3112023-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions5d46ef3c-0dee-4389-a2d5-997ea83428172023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997229donepezil HCl 5 MG Oral TabletPSN93dddf28-094b-dd8c-e053-2995a90a63e93
997229donepezil hydrochloride 5 MG Oral TabletSCD93dddf28-094b-dd8c-e053-2995a90a63e93
997229donepezil HCl 5 MG Oral TabletPSN92fce88e-9fdf-43a8-e053-2995a90a58671
997229donepezil HCl 5 MG Oral TabletPSN93dd96a4-3a74-ea7e-e053-2a95a90ab0a41
997229donepezil hydrochloride 5 MG Oral TabletSCD92fce88e-9fdf-43a8-e053-2995a90a58671
997229donepezil hydrochloride 5 MG Oral TabletSCD93dd96a4-3a74-ea7e-e053-2a95a90ab0a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-031-607218900316060 TABLET, FILM COATED in 1 BOTTLE (72189-031-60) 2019-10-010000-00-00NoNoCurrent