FDA.reportPublic FDA data

Donepezil Hydrochloride

Product NDC
33342-029
11-digit product format
333420029
Labeler code
33342
Product ID
33342-029_4bf742a3-3c8f-4bd3-b973-54370cbef345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA201787
Marketing category
ANDA
Marketing start
2012-12-14
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
Rxcui997220, 997223, 997226, 997229, 1100184

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
bc94e09e-ba00-42fe-bb88-b0b948d7b8f7Product name120221214
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d7e50b51-94ef-29ef-8273-837d555048c1Product name920160811
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-029-06Donepezil Hydrochloride3 in 1 CARTONTABLET, ORALLY DISINTEGRATING331
33342-029-06Donepezil Hydrochloride10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1031
33342-029-07Donepezil Hydrochloride30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3031
33342-029-12Donepezil Hydrochloride10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1031
33342-029-12Donepezil Hydrochloride10 in 1 CARTONTABLET, ORALLY DISINTEGRATING1031
33342-029-60Donepezil Hydrochloride4 in 1 CARTONTABLET, ORALLY DISINTEGRATING431
33342-029-60Donepezil Hydrochloride7 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING731
33342-029-06Donepezil Hydrochloride10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1016
33342-029-06Donepezil Hydrochloride3 in 1 CARTONTABLET, ORALLY DISINTEGRATING316
33342-029-07Donepezil Hydrochloride30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3016
33342-029-12Donepezil Hydrochloride10 in 1 CARTONTABLET, ORALLY DISINTEGRATING1016
33342-029-12Donepezil Hydrochloride10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1016
33342-029-60Donepezil Hydrochloride7 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING716
33342-029-60Donepezil Hydrochloride4 in 1 CARTONTABLET, ORALLY DISINTEGRATING416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-029-07EA - Each33342-0291dc29fe4-50a5-428f-913f-dab1ddeebce812013-10-17
33342-029-60EA - Each33342-029d6629212-7096-4725-b861-23a5cad9ac5412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31
MANNITOLINACTIVE INGREDIENT3OWL53L36ADONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-029DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]31Current NDC, Legacy NDC, 7 package rows20150901_e1e203cd-fd4c-4046-810b-5d7aea47525e.zip
33342-029DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]16Current NDC, Legacy NDC, 7 package rows20230817_06dd25a5-1bf2-446d-ad75-ff9d55117660.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997220donepezil HCl 10 MG Disintegrating Oral TabletPSNe1e203cd-fd4c-4046-810b-5d7aea47525e31
997226donepezil HCl 5 MG Disintegrating Oral TabletPSNe1e203cd-fd4c-4046-810b-5d7aea47525e31
997220donepezil hydrochloride 10 MG Disintegrating Oral TabletSCDe1e203cd-fd4c-4046-810b-5d7aea47525e31
997226donepezil hydrochloride 5 MG Disintegrating Oral TabletSCDe1e203cd-fd4c-4046-810b-5d7aea47525e31
997220donepezil HCl 10 MG Disintegrating Oral TabletPSN06dd25a5-1bf2-446d-ad75-ff9d5511766016
997223donepezil HCl 10 MG Oral TabletPSN06dd25a5-1bf2-446d-ad75-ff9d5511766016
1100184donepezil HCl 23 MG Oral TabletPSN06dd25a5-1bf2-446d-ad75-ff9d5511766016
997226donepezil HCl 5 MG Disintegrating Oral TabletPSN06dd25a5-1bf2-446d-ad75-ff9d5511766016
997229donepezil HCl 5 MG Oral TabletPSN06dd25a5-1bf2-446d-ad75-ff9d5511766016
997220donepezil hydrochloride 10 MG Disintegrating Oral TabletSCD06dd25a5-1bf2-446d-ad75-ff9d5511766016
997223donepezil hydrochloride 10 MG Oral TabletSCD06dd25a5-1bf2-446d-ad75-ff9d5511766016
1100184donepezil hydrochloride 23 MG Oral TabletSCD06dd25a5-1bf2-446d-ad75-ff9d5511766016
997226donepezil hydrochloride 5 MG Disintegrating Oral TabletSCD06dd25a5-1bf2-446d-ad75-ff9d5511766016
997229donepezil hydrochloride 5 MG Oral TabletSCD06dd25a5-1bf2-446d-ad75-ff9d5511766016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-029-06333420029063 BLISTER PACK in 1 CARTON (33342-029-06) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2012-12-140000-00-00NoNoCurrent
33342-029-073334200290730 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-029-07) 2012-12-140000-00-00NoNoCurrent
33342-029-123334200291210 BLISTER PACK in 1 CARTON (33342-029-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2012-12-140000-00-00NoNoCurrent
33342-029-60333420029604 BLISTER PACK in 1 CARTON (33342-029-60) / 7 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2012-12-140000-00-00NoNoCurrent