FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
71093-127
11-digit product format
710930127
Labeler code
71093
Product ID
71093-127_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
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

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 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
71093-127-01Donepezil Hydrochloride30 in 1 BOTTLETABLET3010
71093-127-03Donepezil Hydrochloride90 in 1 BOTTLETABLET9010
71093-127-05Donepezil Hydrochloride500 in 1 BOTTLETABLET50010
71093-127-06Donepezil Hydrochloride1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-127-01EA - Each71093-127561fab43-b88b-4c75-801b-ae4c1e1a824212021-09-07
71093-127-03EA - Each71093-127cfeb2ab2-4d11-489b-9ed1-94226d6ae51f12021-09-07
71093-127-05EA - Each71093-12755197f0b-ed41-45e5-bc62-89dd770a958912021-09-07
71093-127-06EA - Each71093-127b378e249-1a89-4291-bdc1-0baee65a7be512022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-127DONEPEZIL 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
997229donepezil HCl 5 MG Oral TabletPSNecf91436-9de1-44bb-8366-8551479c86a9104
997229donepezil hydrochloride 5 MG Oral TabletSCDecf91436-9de1-44bb-8366-8551479c86a9104
997229donepezil HCl 5 MG Oral TabletPSN385d2fb5-814c-44bd-ac7b-8857d18f144b103
997229donepezil hydrochloride 5 MG Oral TabletSCD385d2fb5-814c-44bd-ac7b-8857d18f144b103
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
997229donepezil HCl 5 MG Oral TabletPSNee54a472-6783-41df-b8bb-9c3e4c9969073
997229donepezil hydrochloride 5 MG Oral TabletSCDee54a472-6783-41df-b8bb-9c3e4c9969073
997229donepezil HCl 5 MG Oral TabletPSN29277dcd-8e0d-d424-e063-6294a90a907e1
997229donepezil hydrochloride 5 MG Oral TabletSCD29277dcd-8e0d-d424-e063-6294a90a907e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71093-127-017109301270130 TABLET in 1 BOTTLE (71093-127-01) 30 tablet2021-06-290000-00-00NoNoCurrent
71093-127-037109301270390 TABLET in 1 BOTTLE (71093-127-03) 90 tablet2021-06-290000-00-00NoNoCurrent
71093-127-0571093012705500 TABLET in 1 BOTTLE (71093-127-05) 500 tablet2021-06-290000-00-00NoNoCurrent
71093-127-06710930127061000 TABLET in 1 BOTTLE (71093-127-06) 1000 tablet2021-06-290000-00-00NoNoCurrent