FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
13668-103
11-digit product format
136680103
Labeler code
13668
Product ID
13668-103_bc153659-2091-4682-a63b-8735e1146bac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090686
Marketing category
ANDA
Marketing start
2011-05-31
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donepezil Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DONEPEZIL HYDROCHLORIDE10 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13668-103-052021-07-14C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-102021-07-14C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-262021-07-14C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-302021-07-14C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-742021-07-14C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-902021-07-14C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-052021-01-29C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-102021-01-29C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-262021-01-29C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-302021-01-29C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-742021-01-29C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996
13668-103-902021-01-29C16284748780-1ba0f9c33-4dc3-a910-e053-dadaa90a0b85These 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 Rx Only Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-103-05Donepezil Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50016
13668-103-10Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100016
13668-103-26Donepezil Hydrochloride2650 in 1 BOTTLETABLET, FILM COATED265016
13668-103-30Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3016
13668-103-90Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-103-05EA - Each13668-103af76ce4a-aa21-4350-b88f-dbf1dbe9f40512012-07-24
13668-103-10EA - Each13668-103f78f05eb-c179-42c2-bbbb-383c0927042312012-07-24
13668-103-26EA - Each13668-10397ce1238-e0b9-4735-b439-bd96bcf8c37b12012-07-24
13668-103-30EA - Each13668-103017d9166-50f0-4773-93a4-c748d6c817fa12012-07-24
13668-103-74EA - Each13668-103ea87716a-faef-4e02-924d-fe6163feb2eb12012-07-24
13668-103-90EA - Each13668-103238ca543-73c0-406f-938e-060f35e9841d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]4
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-103DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]15Current NDC, Legacy NDC, 5 package rows20250122_76bf638e-dbde-418e-8977-1caf009990bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN76bf638e-dbde-418e-8977-1caf009990bc16
997229donepezil HCl 5 MG Oral TabletPSN76bf638e-dbde-418e-8977-1caf009990bc16
997223donepezil hydrochloride 10 MG Oral TabletSCD76bf638e-dbde-418e-8977-1caf009990bc16
997229donepezil hydrochloride 5 MG Oral TabletSCD76bf638e-dbde-418e-8977-1caf009990bc16
997223donepezil HCl 10 MG Oral TabletPSNc777ddc9-0b61-4d6f-95d6-818ba1861d626
997229donepezil HCl 5 MG Oral TabletPSNc777ddc9-0b61-4d6f-95d6-818ba1861d626
997223donepezil hydrochloride 10 MG Oral TabletSCDc777ddc9-0b61-4d6f-95d6-818ba1861d626
997229donepezil hydrochloride 5 MG Oral TabletSCDc777ddc9-0b61-4d6f-95d6-818ba1861d626
997223donepezil HCl 10 MG Oral TabletPSN4b60c43a-d03c-4661-b865-3636f4527b084
997223donepezil hydrochloride 10 MG Oral TabletSCD4b60c43a-d03c-4661-b865-3636f4527b084
997223donepezil HCl 10 MG Oral TabletPSNec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997229donepezil HCl 5 MG Oral TabletPSNec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997223donepezil hydrochloride 10 MG Oral TabletSCDec5cc9e9-aa3a-4c54-b0a1-de1449701f781
997229donepezil hydrochloride 5 MG Oral TabletSCDec5cc9e9-aa3a-4c54-b0a1-de1449701f781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-103-0513668010305500 TABLET, FILM COATED in 1 BOTTLE (13668-103-05) 2011-05-310000-00-00NoNoCurrent
13668-103-10136680103101000 TABLET, FILM COATED in 1 BOTTLE (13668-103-10) 2011-05-310000-00-00NoNoCurrent
13668-103-26136680103262650 TABLET, FILM COATED in 1 BOTTLE (13668-103-26) 2011-05-310000-00-00NoNoCurrent
13668-103-301366801033030 TABLET, FILM COATED in 1 BOTTLE (13668-103-30) 2011-05-310000-00-00NoNoCurrent
13668-103-7413668010374100 TABLET, FILM COATED in 1 CARTON (13668-103-74) 2011-05-310000-00-00NoNoCurrent
13668-103-901366801039090 TABLET, FILM COATED in 1 BOTTLE (13668-103-90) 2011-05-310000-00-00NoNoCurrent