FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
62332-092
11-digit product format
623320092
Labeler code
62332
Product ID
62332-092_cd86384e-917a-41f3-9d71-900c45d83651
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA201724
Marketing category
ANDA
Marketing start
2016-01-29
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
62332-092-10Donepezil Hydrochloride100 in 1 CARTONTABLET, FILM COATED10010
62332-092-30Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010
62332-092-90Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9010
62332-092-91Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-092-30EA - Each62332-092dd3a45e9-355e-4539-9808-9258f87e0b0212016-04-04
62332-092-90EA - Each62332-09242d0d629-c9da-4f20-accc-0d5c0720d37612016-04-04
62332-092-91EA - Each62332-09275b6b6d3-223e-4bbd-a800-163d8a8c4e3e12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-092DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 4 package rows20211013_9407258b-60ed-4884-a903-885aeedaddf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN9407258b-60ed-4884-a903-885aeedaddf810
997229donepezil HCl 5 MG Oral TabletPSN9407258b-60ed-4884-a903-885aeedaddf810
997223donepezil hydrochloride 10 MG Oral TabletSCD9407258b-60ed-4884-a903-885aeedaddf810
997229donepezil hydrochloride 5 MG Oral TabletSCD9407258b-60ed-4884-a903-885aeedaddf810
997229donepezil HCl 5 MG Oral TabletPSN3ac29f6f-0993-416f-8352-e6c0a5ef3e554
997229donepezil hydrochloride 5 MG Oral TabletSCD3ac29f6f-0993-416f-8352-e6c0a5ef3e554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-092-1062332009210100 TABLET, FILM COATED in 1 CARTON (62332-092-10) 2016-01-290000-00-00NoNoCurrent
62332-092-306233200923030 TABLET, FILM COATED in 1 BOTTLE (62332-092-30) 2016-01-290000-00-00NoNoCurrent
62332-092-906233200929090 TABLET, FILM COATED in 1 BOTTLE (62332-092-90) 2016-01-290000-00-00NoNoCurrent
62332-092-91623320092911000 TABLET, FILM COATED in 1 BOTTLE (62332-092-91) 2016-01-290000-00-00NoNoCurrent