FDA.reportPublic FDA data

Aricept

Product NDC
62856-245
11-digit product format
628560245
Labeler code
62856
Product ID
62856-245_4bc1cba0-8ebe-4b11-b4a4-19148d4249c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
donepezil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Eisai Inc.
Application
NDA020690
Marketing category
NDA
Marketing start
1996-11-25
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
Aricept
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3O2T2PJ89D
Rxcui997220, 997222, 997223, 997224, 997226, 997228, 997229, 997230, 1100184, 1100187

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
62856-245-11Aricept1000 in 1 BOTTLETABLET, FILM COATED100031
62856-245-30Aricept30 in 1 BOTTLETABLET, FILM COATED3031
62856-245-41Aricept10 in 1 CARTONTABLET, FILM COATED1031
62856-245-41Aricept10 in 1 BLISTER PACKTABLET, FILM COATED1031
62856-245-90Aricept90 in 1 BOTTLETABLET, FILM COATED9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62856-245-30EA - Each62856-245b547f9a1-f804-4d6a-8681-1022e0e161a912012-07-24
62856-245-41EA - Each62856-245a7af8cf7-04f3-48c6-a454-16c27a553dd312012-07-24
62856-245-90EA - Each62856-245693a6244-1e89-41a6-8a4b-ed842ccffdc012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
DONEPEZILACTIVE MOIETY8SSC91326PARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
MANNITOLINACTIVE INGREDIENT3OWL53L36AARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
TALCINACTIVE INGREDIENT7SEV7J4R1UARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]16
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
DONEPEZILACTIVE MOIETY8SSC91326PARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62856-245ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLET, FILM COATED ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [EISAI INC.]31Current NDC, Legacy NDC, 5 package rows20231118_98e451e1-e4d7-4439-a675-c5457ba20975.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997224Aricept 10 MG Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
1100187Aricept 23 MG Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
997230Aricept 5 MG Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
997222Aricept ODT 10 MG Disintegrating Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
997228Aricept ODT 5 MG Disintegrating Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
997220donepezil HCl 10 MG Disintegrating Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
997223donepezil HCl 10 MG Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
1100184donepezil HCl 23 MG Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
997226donepezil HCl 5 MG Disintegrating Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
997229donepezil HCl 5 MG Oral TabletPSN98e451e1-e4d7-4439-a675-c5457ba2097531
997222donepezil hydrochloride 10 MG Disintegrating Oral Tablet [Aricept]SBD98e451e1-e4d7-4439-a675-c5457ba2097531
997224donepezil hydrochloride 10 MG Oral Tablet [Aricept]SBD98e451e1-e4d7-4439-a675-c5457ba2097531
1100187donepezil hydrochloride 23 MG Oral Tablet [Aricept]SBD98e451e1-e4d7-4439-a675-c5457ba2097531
997228donepezil hydrochloride 5 MG Disintegrating Oral Tablet [Aricept]SBD98e451e1-e4d7-4439-a675-c5457ba2097531
997230donepezil hydrochloride 5 MG Oral Tablet [Aricept]SBD98e451e1-e4d7-4439-a675-c5457ba2097531
997220donepezil hydrochloride 10 MG Disintegrating Oral TabletSCD98e451e1-e4d7-4439-a675-c5457ba2097531
997223donepezil hydrochloride 10 MG Oral TabletSCD98e451e1-e4d7-4439-a675-c5457ba2097531
1100184donepezil hydrochloride 23 MG Oral TabletSCD98e451e1-e4d7-4439-a675-c5457ba2097531
997226donepezil hydrochloride 5 MG Disintegrating Oral TabletSCD98e451e1-e4d7-4439-a675-c5457ba2097531
997229donepezil hydrochloride 5 MG Oral TabletSCD98e451e1-e4d7-4439-a675-c5457ba2097531
997222Aricept 10 MG Disintegrating Oral TabletSY98e451e1-e4d7-4439-a675-c5457ba2097531
997224Aricept 10 MG Oral TabletSY98e451e1-e4d7-4439-a675-c5457ba2097531
1100187Aricept 23 MG Oral TabletSY98e451e1-e4d7-4439-a675-c5457ba2097531
997228Aricept 5 MG Disintegrating Oral TabletSY98e451e1-e4d7-4439-a675-c5457ba2097531
997230Aricept 5 MG Oral TabletSY98e451e1-e4d7-4439-a675-c5457ba2097531
997222Aricept ODT 10 MG Disintegrating Oral TabletSY98e451e1-e4d7-4439-a675-c5457ba2097531
997228Aricept ODT 5 MG Disintegrating Oral TabletSY98e451e1-e4d7-4439-a675-c5457ba2097531
997224Aricept 10 MG Oral TabletPSNd9d15879-3883-4963-9c93-73d5251484fa2
997230Aricept 5 MG Oral TabletPSNd9d15879-3883-4963-9c93-73d5251484fa2
997223donepezil HCl 10 MG Oral TabletPSNd9d15879-3883-4963-9c93-73d5251484fa2
997229donepezil HCl 5 MG Oral TabletPSNd9d15879-3883-4963-9c93-73d5251484fa2
997224donepezil hydrochloride 10 MG Oral Tablet [Aricept]SBDd9d15879-3883-4963-9c93-73d5251484fa2
997230donepezil hydrochloride 5 MG Oral Tablet [Aricept]SBDd9d15879-3883-4963-9c93-73d5251484fa2
997223donepezil hydrochloride 10 MG Oral TabletSCDd9d15879-3883-4963-9c93-73d5251484fa2
997229donepezil hydrochloride 5 MG Oral TabletSCDd9d15879-3883-4963-9c93-73d5251484fa2
997224Aricept 10 MG Oral TabletSYd9d15879-3883-4963-9c93-73d5251484fa2
997230Aricept 5 MG Oral TabletSYd9d15879-3883-4963-9c93-73d5251484fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62856-245-11628560245111000 in 1 BOTTLEHistorical
62856-245-306285602453030 TABLET, FILM COATED in 1 BOTTLE (62856-245-30) 1996-11-250000-00-00NoNoCurrent
62856-245-416285602454110 in 1 CARTONHistorical
62856-245-906285602459090 in 1 BOTTLEHistorical