FDA.reportPublic FDA data

donepezil hydrochloride

Product NDC
67046-144
11-digit product format
670460144
Labeler code
67046
Product ID
67046-144_7d660533-be78-7ee4-e053-2a91aa0a7baf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA200292
Marketing category
ANDA
Marketing start
2017-09-19
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
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-144IInactivated by FDA2026-07-31
excluded packagepackage67046-14467046-144-07IInactivated by FDA2026-07-31
excluded packagepackage67046-14467046-144-14IInactivated by FDA2026-07-31
excluded packagepackage67046-14467046-144-15IInactivated by FDA2026-07-31
excluded packagepackage67046-14467046-144-21IInactivated by FDA2026-07-31
excluded packagepackage67046-14467046-144-28IInactivated by FDA2026-07-31
excluded packagepackage67046-14467046-144-30IInactivated by FDA2026-07-31

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
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 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
67046-144-072022-01-28C16284748780-1d6a99b39-3545-a426-e053-dadaa90af4c2These 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, for oral use 144 Initial U.S. Approval: 1996
67046-144-142022-01-28C16284748780-1d6a99b39-3545-a426-e053-dadaa90af4c2These 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, for oral use 144 Initial U.S. Approval: 1996
67046-144-152022-01-28C16284748780-1d6a99b39-3545-a426-e053-dadaa90af4c2These 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, for oral use 144 Initial U.S. Approval: 1996
67046-144-212022-01-28C16284748780-1d6a99b39-3545-a426-e053-dadaa90af4c2These 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, for oral use 144 Initial U.S. Approval: 1996
67046-144-282022-01-28C16284748780-1d6a99b39-3545-a426-e053-dadaa90af4c2These 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, for oral use 144 Initial U.S. Approval: 1996
67046-144-302022-01-28C16284748780-1d6a99b39-3545-a426-e053-dadaa90af4c2These 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, for oral use 144 Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-144-07donepezil hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED72
67046-144-14donepezil hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED142
67046-144-15donepezil hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED152
67046-144-21donepezil hydrochloride21 in 1 BLISTER PACKTABLET, FILM COATED212
67046-144-28donepezil hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED282
67046-144-30donepezil hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-144DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 6 package rows20181220_598bd4d0-18bc-2542-e053-2991aa0a0762.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN598bd4d0-18bc-2542-e053-2991aa0a07622
997223donepezil hydrochloride 10 MG Oral TabletSCD598bd4d0-18bc-2542-e053-2991aa0a07622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-144-07670460144077 TABLET, FILM COATED in 1 BLISTER PACK (67046-144-07) 2017-09-190000-00-00NoNoCurrent
67046-144-146704601441414 TABLET, FILM COATED in 1 BLISTER PACK (67046-144-14) 2017-09-190000-00-00NoNoCurrent
67046-144-156704601441515 TABLET, FILM COATED in 1 BLISTER PACK (67046-144-15) 2017-09-190000-00-00NoNoCurrent
67046-144-216704601442121 TABLET, FILM COATED in 1 BLISTER PACK (67046-144-21) 2017-09-190000-00-00NoNoCurrent
67046-144-286704601442828 TABLET, FILM COATED in 1 BLISTER PACK (67046-144-28) 2017-09-190000-00-00NoNoCurrent
67046-144-306704601443030 TABLET, FILM COATED in 1 BLISTER PACK (67046-144-30) 2017-09-190000-00-00NoNoCurrent