FDA.reportPublic FDA data

DONEPEZIL HYDROCHLORIDE

Product NDC
72189-031
Requested package NDC
72189-031-90
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72189-03172189-031-90IInactivated by FDA2026-08-03

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31a50c72e98297…
2026-08-01 22:54:322026-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200292-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A200292-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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
72189-031-907218900319090 TABLET, FILM COATED in 1 BOTTLE (72189-031-90) 2019-09-200000-00-00NoNoCurrent