Donepezil Hydrochloride

Product NDC
62756-194
11-digit product format
627560194
Labeler code
62756
Product ID
62756-194_65890f83-ea1b-4342-b403-6ebe155bc357
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA204293
Marketing category
ANDA
Marketing start
2015-06-17
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
23 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
3O2T2PJ89DDONEPEZIL HYDROCHLORIDE120011-70-3DONEPEZIL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62756-194-18627560194181000 TABLET, FILM COATED in 1 BOTTLE (62756-194-18) 2015-06-17NoNoHistorical
62756-194-816275601948190 TABLET, FILM COATED in 1 BOTTLE (62756-194-81) 2015-06-17NoNoHistorical
62756-194-836275601948330 TABLET, FILM COATED in 1 BOTTLE (62756-194-83) 2015-06-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Donepezil HydrochlorideSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2018-10-31Human Prescription Drug Label8