FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
0904-6478
11-digit product format
009046478
Labeler code
0904
Product ID
0904-6478_cb092ac4-5569-4fbf-88bd-8b3037a946fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090686
Marketing category
ANDA
Marketing start
2011-05-28
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil Hydrochloride
Listing expiration
2027-12-31

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
0904-6478-61Donepezil Hydrochloride100 in 1 CARTONTABLET, FILM COATED1006
0904-6478-61Donepezil Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6478-61EA - Each0904-64784008c5a3-2269-40ab-949e-5d78efabfc2112018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6478DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4Current NDC, Legacy NDC, 2 package rows20250216_c777ddc9-0b61-4d6f-95d6-818ba1861d62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSNc942a4c9-dbe5-4131-bb6c-aa2d31b387e710
997229donepezil HCl 5 MG Oral TabletPSNc942a4c9-dbe5-4131-bb6c-aa2d31b387e710
997223donepezil hydrochloride 10 MG Oral TabletSCDc942a4c9-dbe5-4131-bb6c-aa2d31b387e710
997229donepezil hydrochloride 5 MG Oral TabletSCDc942a4c9-dbe5-4131-bb6c-aa2d31b387e710
997223donepezil HCl 10 MG Oral TabletPSNc777ddc9-0b61-4d6f-95d6-818ba1861d626
997229donepezil HCl 5 MG Oral TabletPSNc777ddc9-0b61-4d6f-95d6-818ba1861d626
997223donepezil hydrochloride 10 MG Oral TabletSCDc777ddc9-0b61-4d6f-95d6-818ba1861d626
997229donepezil hydrochloride 5 MG Oral TabletSCDc777ddc9-0b61-4d6f-95d6-818ba1861d626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6478-6100904647861100 BLISTER PACK in 1 CARTON (0904-6478-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2011-05-280000-00-00NoNoCurrent