FDA.reportPublic FDA data

Donepezil

Product NDC
31722-738
11-digit product format
317220738
Labeler code
31722
Product ID
31722-738_2b1d0795-adc8-39e4-e063-6294a90a91cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Donepezil hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203034
Marketing category
ANDA
Marketing start
2015-02-02
Substance
DONEPEZIL HYDROCHLORIDE
Active strength
10 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
Listing expiration
2026-12-31

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
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
31722-738-012020-02-06C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-052020-02-06C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-302020-02-06C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-312020-02-06C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-902020-02-06C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-012020-01-31C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-052020-01-31C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-302020-01-31C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-312020-01-31C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-902020-01-31C16284748780-19d75b9d0-a56a-f424-e053-dadaa90a57ceThese 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
31722-738-01Donepezil100 in 1 BOTTLETABLET1006
31722-738-05Donepezil500 in 1 BOTTLETABLET5006
31722-738-30Donepezil30 in 1 BOTTLETABLET306
31722-738-31Donepezil100 in 1 BLISTER PACKTABLET1006
31722-738-90Donepezil90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-738-05EA - Each31722-73820b2b3d7-7846-4a81-8391-d976aa28b85412016-11-08
31722-738-30EA - Each31722-738e162fdad-b6b1-4ecf-8263-e2f11e735e6d12015-10-02
31722-738-90EA - Each31722-738a261d496-f076-4bc0-8955-d61af6f4347f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DONEPEZIL HYDROCHLORIDEACTIVE INGREDIENT3O2T2PJ89DDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
DONEPEZILACTIVE MOIETY8SSC91326PDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-738DONEPEZIL (DONEPEZIL HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 5 package rows20250109_11ac01f4-d26e-47b2-9660-d514ab097fdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997223donepezil HCl 10 MG Oral TabletPSN84d8ca68-26f3-4dd5-9dd4-6a7525a30db126
997229donepezil HCl 5 MG Oral TabletPSN84d8ca68-26f3-4dd5-9dd4-6a7525a30db126
997223donepezil hydrochloride 10 MG Oral TabletSCD84d8ca68-26f3-4dd5-9dd4-6a7525a30db126
997229donepezil hydrochloride 5 MG Oral TabletSCD84d8ca68-26f3-4dd5-9dd4-6a7525a30db126
997223donepezil HCl 10 MG Oral TabletPSN12ae85f0-023c-49ca-8c4a-0a6a7585290e7
997229donepezil HCl 5 MG Oral TabletPSN12ae85f0-023c-49ca-8c4a-0a6a7585290e7
997223donepezil hydrochloride 10 MG Oral TabletSCD12ae85f0-023c-49ca-8c4a-0a6a7585290e7
997229donepezil hydrochloride 5 MG Oral TabletSCD12ae85f0-023c-49ca-8c4a-0a6a7585290e7
997223donepezil HCl 10 MG Oral TabletPSN11ac01f4-d26e-47b2-9660-d514ab097fdb6
997229donepezil HCl 5 MG Oral TabletPSN11ac01f4-d26e-47b2-9660-d514ab097fdb6
997223donepezil hydrochloride 10 MG Oral TabletSCD11ac01f4-d26e-47b2-9660-d514ab097fdb6
997229donepezil hydrochloride 5 MG Oral TabletSCD11ac01f4-d26e-47b2-9660-d514ab097fdb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-738-0131722073801100 TABLET in 1 BOTTLE (31722-738-01) 100 tablet2015-02-020000-00-00NoNoCurrent
31722-738-0531722073805500 TABLET in 1 BOTTLE (31722-738-05) 500 tablet2015-02-020000-00-00NoNoCurrent
31722-738-303172207383030 TABLET in 1 BOTTLE (31722-738-30) 30 tablet2015-02-020000-00-00NoNoCurrent
31722-738-3131722073831100 TABLET in 1 BLISTER PACK (31722-738-31) 100 tablet2015-02-020000-00-00NoNoCurrent
31722-738-903172207389090 TABLET in 1 BOTTLE (31722-738-90) 90 tablet2015-02-020000-00-00NoNoCurrent