FDA.reportPublic FDA data

NDC 68788-8711-09 - Donepezil Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68788-8711
Requested NDC
68788-8711-09
Package NDCs from labels
68788-8711-3, 68788-8711-6, 68788-8711-9, 68788-8711-09
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-04-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Donepezil Hydrochloride - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2026-04-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8711-3Donepezil Hydrochloride30 in 1 BOTTLETABLET303
68788-8711-6Donepezil Hydrochloride60 in 1 BOTTLETABLET603
68788-8711-9Donepezil Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8711DONEPEZIL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20250406_ee54a472-6783-41df-b8bb-9c3e4c996907.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8711-3EA - Each68788-871176192a7a-0ac4-4606-bf51-43ec25a7de7812024-09-09
68788-8711-6EA - Each68788-8711ee2eedc6-05fb-4fa8-b244-2e5702641b8f12024-09-09
68788-8711-9EA - Each68788-8711d6f89586-785a-4d91-8846-0f396566a0b912024-09-09

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 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DonepezilDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.37fc6638-4a63-4582-a64c-3525f8ed7ef22026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.de96349a-5fee-4de9-921c-e453d44b32032026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions0516d548-db9b-410a-aec9-79aedbc3f6e92026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEGolden State Medical Supply, Inc.a085ed33-c262-44ab-e053-2a95a90a55572026-05-27Warnings, Adverse reactionsExact identifier
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEUpsher-Smith Laboratories, LLC12a755c5-1ad9-43d1-832a-eb2ff17bd6932026-05-08Warnings, Adverse reactionsExact identifier
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDECardinal Health 107, LLCc942a4c9-dbe5-4131-bb6c-aa2d31b387e72026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.ee54a472-6783-41df-b8bb-9c3e4c9969072026-04-08Warnings, Adverse reactionsExact identifier
application number: ANDA078662
ndc (package): 68788-8711-9
ndc (package): 68788-8711-3
ndc (package): 68788-8711-6
ndc (product): 68788-8711
ndc11 (package): 68788871109
rxcui: 997229
spl id: c9fdb857-2048-40fe-a3d1-4e89dda6cdf4
spl set id: ee54a472-6783-41df-b8bb-9c3e4c996907
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.8138f616-83f3-4c47-84ef-1bce2db339f72026-04-08Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.41c095b6-acd9-4627-a813-bbca7ecafee52026-03-30Warnings, Adverse reactionsExact identifier
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEGolden State Medical Supply, Inc.56abe961-ec94-4a77-b548-426f6255539e2026-03-09Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
NamzaricMEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEAllergan, Inc.90fedc32-19e5-480c-afc6-f35a5cf4b9aa2026-03-06Warnings, Adverse reactionsExact identifier
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEMajor Pharmaceuticalsc777ddc9-0b61-4d6f-95d6-818ba1861d622026-02-19Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDETorrent Pharmaceuticals Limited76bf638e-dbde-418e-8977-1caf009990bc2026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
Donepezil HydrochlorideDONEPEZIL HYDROCHLORIDEScieGen Pharmaceuticals, Inc.6e9aacf9-abb6-4dec-9a8d-4eabf934d5122026-01-30Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
DonepezilDONEPEZIL HYDROCHLORIDEA-S Medication Solutions84d8ca68-26f3-4dd5-9dd4-6a7525a30db12026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.1a8906ce-96dc-4bc8-81c1-5db67a187aac2025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
DonepezilDONEPEZIL HYDROCHLORIDEQuallent Pharmaceuticals Health LLCc7e1f642-1bdc-4ed6-9b9e-c1af40b926cd2025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
DonepezilDONEPEZIL HYDROCHLORIDEAmerican Health Packaging12ae85f0-023c-49ca-8c4a-0a6a7585290e2025-09-24Warnings, Adverse reactionsExact identifier
rxcui: 997229
unii: 3O2T2PJ89D
Donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.11404dc3-1bde-4d4e-8386-006b67ee19dd2025-08-01Warnings, Adverse reactionsExact identifier
unii: 3O2T2PJ89D
Memantine and DonepezilMEMANTINE AND DONEPEZILMacleods Pharmaceuticals Limited3d9a23dc-8cbe-47c3-a048-70d86cb9dc142025-07-10Warnings, Adverse reactionsExact identifier
unii: 3O2T2PJ89D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.