FDA.reportPublic FDA data

Donepezil hydrochloride

Product NDC
55111-356
11-digit product format
551110356
Labeler code
55111
Product ID
55111-356_d6af4584-b379-0cea-78b6-a493f88708c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddys Laboratories Limited
Application
ANDA201001
Marketing category
ANDA
Marketing start
2011-05-31
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
55111-356-05Donepezil hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011
55111-356-10Donepezil hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100011
55111-356-30Donepezil hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011
55111-356-78Donepezil hydrochloride10 in 1 CARTONTABLET, FILM COATED1011
55111-356-79Donepezil hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1011
55111-356-90Donepezil hydrochloride90 in 1 BOTTLETABLET, FILM COATED9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-356DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]11Current NDC, Legacy NDC, 6 package rows20241222_4c9889fd-2cb3-02da-f034-46120acc38c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN4c9889fd-2cb3-02da-f034-46120acc38c311
997229donepezil HCl 5 MG Oral TabletPSN4c9889fd-2cb3-02da-f034-46120acc38c311
997223donepezil hydrochloride 10 MG Oral TabletSCD4c9889fd-2cb3-02da-f034-46120acc38c311
997229donepezil hydrochloride 5 MG Oral TabletSCD4c9889fd-2cb3-02da-f034-46120acc38c311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-356-0555111035605500 TABLET, FILM COATED in 1 BOTTLE (55111-356-05) 2011-05-310000-00-00NoNoCurrent
55111-356-10551110356101000 TABLET, FILM COATED in 1 BOTTLE (55111-356-10) 2011-05-310000-00-00NoNoCurrent
55111-356-305511103563030 TABLET, FILM COATED in 1 BOTTLE (55111-356-30) 2011-05-310000-00-00NoNoCurrent
55111-356-785511103567810 BLISTER PACK in 1 CARTON (55111-356-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-356-79) 10 blister pack2011-05-310000-00-00NoNoCurrent
55111-356-795511103567910 in 1 BLISTER PACKHistorical
55111-356-905511103569090 TABLET, FILM COATED in 1 BOTTLE (55111-356-90) 2011-05-310000-00-00NoNoCurrent