FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
0615-8313
11-digit product format
006158313
Labeler code
0615
Product ID
0615-8313_d950c91f-51cd-4f96-8562-971798db2edf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA201146
Marketing category
ANDA
Marketing start
2012-08-17
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

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
0615-8313-05Donepezil Hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED1517
0615-8313-28Donepezil Hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED2817
0615-8313-30Donepezil Hydrochloride5 in 1 BLISTER PACKTABLET, FILM COATED517
0615-8313-30Donepezil Hydrochloride6 in 1 BOX, UNIT-DOSETABLET, FILM COATED617
0615-8313-39Donepezil Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8313DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]17Current NDC, Legacy NDC, 5 package rows20250110_7620f41a-3eef-453b-a564-ea3c85374de2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN7620f41a-3eef-453b-a564-ea3c85374de217
997223donepezil hydrochloride 10 MG Oral TabletSCD7620f41a-3eef-453b-a564-ea3c85374de217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8313-050061583130515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-05) 2019-08-210000-00-00NoNoCurrent
0615-8313-280061583132828 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-28) 2025-01-06NoNoCurrent
0615-8313-30006158313306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8313-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2019-08-190000-00-00NoNoCurrent
0615-8313-390061583133930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-39) 2019-08-210000-00-00NoNoCurrent