FDA.reportPublic FDA data

donepezil hydrochloride

Product NDC
68788-7732
11-digit product format
687887732
Labeler code
68788
Product ID
68788-7732_2a8f3351-bafd-434c-8c72-3d6935c6288c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA200292
Marketing category
ANDA
Marketing start
2020-07-01
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
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7732DDiscontinued by firm2026-08-03
excluded packagepackage68788-773268788-7732-3DDiscontinued by firm2026-08-03
excluded packagepackage68788-773268788-7732-6DDiscontinued by firm2026-08-03
excluded packagepackage68788-773268788-7732-9DDiscontinued by firm2026-08-03

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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7732-3EA - Each68788-77324c8accfd-5bba-409a-b1fa-ab1c09658a4512020-09-14
68788-7732-6EA - Each68788-773251bf8ba3-ad08-4d8b-8792-d306463fde3112020-09-14
68788-7732-9EA - Each68788-7732e3984c9b-927a-4209-815f-f3bdf9e5e71612020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7732-36878877320330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7732-3) 2020-07-010000-00-00NoNoCurrent
68788-7732-66878877320660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7732-6) 2020-07-010000-00-00NoNoCurrent
68788-7732-96878877320990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7732-9) 2020-07-010000-00-00NoNoCurrent