FDA.reportPublic FDA data

Donepezil hydrochloride

Product NDC
55111-302
11-digit product format
551110302
Labeler code
55111
Product ID
55111-302_0df6bfb2-4604-2035-9677-06c125e77bb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddys Laboratories Limited
Application
ANDA202723
Marketing category
ANDA
Marketing start
2025-08-20
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

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE23 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui1100184

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55111-302-052025-03-04C16284748780-12cef2736-96a5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
55111-302-102025-03-04C16284748780-12cef2736-96a5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
55111-302-302025-03-04C16284748780-12cef2736-96a5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
55111-302-902025-03-04C16284748780-12cef2736-96a5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
55111-302-052025-01-30C16284748780-12cef2736-96a5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
55111-302-102025-01-30C16284748780-12cef2736-96a5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
55111-302-302025-01-30C16284748780-12cef2736-96a5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996
55111-302-902025-01-30C16284748780-12cef2736-96a5-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-302-30Donepezil hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010
55111-302-90Donepezil hydrochloride90 in 1 BOTTLETABLET, FILM COATED9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-302-30EA - Each55111-302c8d06ac6-175e-4ae6-ab4d-64f00e28a32412013-08-02
55111-302-90EA - Each55111-302067a7fc3-233e-43b0-9ee7-d8d8969468ef12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
DonepezilACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [DR. REDDYS LABORATORIES LIMITED]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100184donepezil HCl 23 MG Oral TabletPSN7c0d3bcb-157d-0414-64ee-055bc614d19010
1100184donepezil hydrochloride 23 MG Oral TabletSCD7c0d3bcb-157d-0414-64ee-055bc614d19010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-302-0555111030205500 TABLET, FILM COATED in 1 BOTTLE (55111-302-05) 2013-07-260000-00-00NoNoCurrent
55111-302-10551110302101000 TABLET, FILM COATED in 1 BOTTLE (55111-302-10) 2013-07-260000-00-00NoNoCurrent
55111-302-305511103023030 TABLET, FILM COATED in 1 BOTTLE (55111-302-30) 2025-08-200000-00-00NoNoCurrent
55111-302-905511103029090 TABLET, FILM COATED in 1 BOTTLE (55111-302-90) 2025-08-200000-00-00NoNoCurrent