FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
63304-129
11-digit product format
633040129
Labeler code
63304
Product ID
63304-129_e045a98a-fd37-48c0-ba67-2889a4666d8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076786
Marketing category
ANDA
Marketing start
2010-11-29
Marketing end
0000-00-00
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63304-129-102020-01-31C16284748780-19d75b9d0-2b96-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DONEPEZIL hydrochloride tablets, USP safely and effectively. See full prescribing information for DONEPEZIL hydrochloride tablets, USP. DONEPEZIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1996
63304-129-202020-01-31C16284748780-19d75b9d0-2b96-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DONEPEZIL hydrochloride tablets, USP safely and effectively. See full prescribing information for DONEPEZIL hydrochloride tablets, USP. DONEPEZIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1996
63304-129-302020-01-31C16284748780-19d75b9d0-2b96-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DONEPEZIL hydrochloride tablets, USP safely and effectively. See full prescribing information for DONEPEZIL hydrochloride tablets, USP. DONEPEZIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1996
63304-129-312020-01-31C16284748780-19d75b9d0-2b96-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DONEPEZIL hydrochloride tablets, USP safely and effectively. See full prescribing information for DONEPEZIL hydrochloride tablets, USP. DONEPEZIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1996
63304-129-772020-01-31C16284748780-19d75b9d0-2b96-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DONEPEZIL hydrochloride tablets, USP safely and effectively. See full prescribing information for DONEPEZIL hydrochloride tablets, USP. DONEPEZIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1996
63304-129-902020-01-31C16284748780-19d75b9d0-2b96-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DONEPEZIL hydrochloride tablets, USP safely and effectively. See full prescribing information for DONEPEZIL hydrochloride tablets, USP. DONEPEZIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-129-10Donepezil Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10007
63304-129-20Donepezil Hydrochloride20 in 1 BOTTLETABLET, FILM COATED207
63304-129-30Donepezil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
63304-129-31Donepezil Hydrochloride3 in 1 CARTONTABLET, FILM COATED37
63304-129-31Donepezil Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED107
63304-129-77Donepezil Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED107
63304-129-77Donepezil Hydrochloride10 in 1 CARTONTABLET, FILM COATED107
63304-129-90Donepezil Hydrochloride90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-129-10EA - Each63304-129748557be-e73b-4e50-9887-ac680b67d23a12012-07-24
63304-129-30EA - Each63304-1297d245821-f6a5-4f30-8a84-f8cc8c224af212012-07-24
63304-129-77EA - Each63304-1299b208cc4-ba36-4e64-bb9a-bb7058a3068812012-07-24
63304-129-90EA - Each63304-12968b69c2c-760c-4e4f-893d-5508b91832d912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-129DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]7Legacy NDC, 8 package rows20131219_4fbb6318-f83f-47ce-ab6c-09e92460bb6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN4fbb6318-f83f-47ce-ab6c-09e92460bb6d7
997229donepezil HCl 5 MG Oral TabletPSN4fbb6318-f83f-47ce-ab6c-09e92460bb6d7
997223donepezil hydrochloride 10 MG Oral TabletSCD4fbb6318-f83f-47ce-ab6c-09e92460bb6d7
997229donepezil hydrochloride 5 MG Oral TabletSCD4fbb6318-f83f-47ce-ab6c-09e92460bb6d7
997223donepezil HCl 10 MG Oral TabletPSN1c845e89-e899-4094-bae6-c14602dbf2882
997229donepezil HCl 5 MG Oral TabletPSN1c845e89-e899-4094-bae6-c14602dbf2882
997223donepezil hydrochloride 10 MG Oral TabletSCD1c845e89-e899-4094-bae6-c14602dbf2882
997229donepezil hydrochloride 5 MG Oral TabletSCD1c845e89-e899-4094-bae6-c14602dbf2882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-129-10633040129101000 in 1 BOTTLEHistorical
63304-129-206330401292020 in 1 BOTTLEHistorical
63304-129-306330401293030 in 1 BOTTLEHistorical
63304-129-31633040129313 in 1 CARTONHistorical
63304-129-776330401297710 in 1 BLISTER PACKHistorical
63304-129-906330401299090 in 1 BOTTLEHistorical