FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
50228-139
11-digit product format
502280139
Labeler code
50228
Product ID
50228-139_652d4a32-9c92-43df-be8a-a91cfaf61c3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA203907
Marketing category
ANDA
Marketing start
2014-10-29
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
5 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 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
50228-139-10Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006
50228-139-30Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-139DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20190330_6e9aacf9-abb6-4dec-9a8d-4eabf934d512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN56abe961-ec94-4a77-b548-426f6255539e8
997229donepezil HCl 5 MG Oral TabletPSN56abe961-ec94-4a77-b548-426f6255539e8
997223donepezil hydrochloride 10 MG Oral TabletSCD56abe961-ec94-4a77-b548-426f6255539e8
997229donepezil hydrochloride 5 MG Oral TabletSCD56abe961-ec94-4a77-b548-426f6255539e8
997223donepezil HCl 10 MG Oral TabletPSN6e9aacf9-abb6-4dec-9a8d-4eabf934d5126
997229donepezil HCl 5 MG Oral TabletPSN6e9aacf9-abb6-4dec-9a8d-4eabf934d5126
997223donepezil hydrochloride 10 MG Oral TabletSCD6e9aacf9-abb6-4dec-9a8d-4eabf934d5126
997229donepezil hydrochloride 5 MG Oral TabletSCD6e9aacf9-abb6-4dec-9a8d-4eabf934d5126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-139-10502280139101000 TABLET, FILM COATED in 1 BOTTLE (50228-139-10) 2014-10-290000-00-00NoNoCurrent
50228-139-305022801393030 TABLET, FILM COATED in 1 BOTTLE (50228-139-30) 2014-10-290000-00-00NoNoCurrent