FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
71093-128
11-digit product format
710930128
Labeler code
71093
Product ID
71093-128_a4736add-da84-411f-8e6f-9de67bf467f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA078662
Marketing category
ANDA
Marketing start
2021-06-29
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997223, 997229

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71093-128-01Donepezil Hydrochloride30 in 1 BOTTLETABLET3010
71093-128-03Donepezil Hydrochloride90 in 1 BOTTLETABLET9010
71093-128-05Donepezil Hydrochloride500 in 1 BOTTLETABLET50010
71093-128-06Donepezil Hydrochloride1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-128-01EA - Each71093-128cc87d038-c744-4378-82fa-f67e6557ca6012021-09-07
71093-128-03EA - Each71093-128c2d65cdb-d4e0-4cd3-8687-a87139fe1fc312021-09-07
71093-128-05EA - Each71093-12817e54205-03d6-4159-8631-f261d917171812021-09-07
71093-128-06EA - Each71093-128b05fcae7-9578-410c-8ba5-f0bf031db6b112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-128DONEPEZIL HYDROCHLORIDE TABLET [ACI HEALTHCARE USA, INC.]10Current NDC, Legacy NDC, 4 package rows20231213_297e86e8-d248-4cc9-9d9c-2ef9efb4414d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN7ab9d0ef-e30c-46e9-9911-435a7b65c47b102
997223donepezil hydrochloride 10 MG Oral TabletSCD7ab9d0ef-e30c-46e9-9911-435a7b65c47b102
997223donepezil HCl 10 MG Oral TabletPSN297e86e8-d248-4cc9-9d9c-2ef9efb4414d10
997229donepezil HCl 5 MG Oral TabletPSN297e86e8-d248-4cc9-9d9c-2ef9efb4414d10
997223donepezil hydrochloride 10 MG Oral TabletSCD297e86e8-d248-4cc9-9d9c-2ef9efb4414d10
997229donepezil hydrochloride 5 MG Oral TabletSCD297e86e8-d248-4cc9-9d9c-2ef9efb4414d10
997223donepezil HCl 10 MG Oral TabletPSN7db089de-0344-4246-81b7-7c88a2a184021
997223donepezil hydrochloride 10 MG Oral TabletSCD7db089de-0344-4246-81b7-7c88a2a184021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-128-017109301280130 TABLET in 1 BOTTLE (71093-128-01) 30 tablet2021-06-290000-00-00NoNoCurrent
71093-128-037109301280390 TABLET in 1 BOTTLE (71093-128-03) 90 tablet2021-06-290000-00-00NoNoCurrent
71093-128-0571093012805500 TABLET in 1 BOTTLE (71093-128-05) 500 tablet2021-06-290000-00-00NoNoCurrent
71093-128-06710930128061000 TABLET in 1 BOTTLE (71093-128-06) 1000 tablet2021-06-290000-00-00NoNoCurrent