NDC 68071-3183

Donepezil

Donepezil Hydrochloride

Donepezil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nucarepharmaceuticals, Inc.. The primary component is Donepezil Hydrochloride.

Product ID68071-3183_51f43966-854f-161b-e054-00144ff88e88
NDC68071-3183
Product TypeHuman Prescription Drug
Proprietary NameDonepezil
Generic NameDonepezil Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-02-02
Marketing CategoryANDA / ANDA
Application NumberANDA203034
Labeler NameNuCarePharmaceuticals, Inc.
Substance NameDONEPEZIL HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68071-3183-3

30 TABLET in 1 BOTTLE (68071-3183-3)
Marketing Start Date2017-06-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-3183-3 [68071318303]

Donepezil TABLET
Marketing CategoryANDA
Application NumberANDA203034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-14
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-07

Drug Details

Active Ingredients

IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:51f43966-854e-161b-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997229
  • Pharmacological Class

    • Cholinesterase Inhibitor [EPC]
    • Cholinesterase Inhibitors [MoA]

    NDC Crossover Matching brand name "Donepezil" or generic name "Donepezil Hydrochloride"

    NDCBrand NameGeneric Name
    68071-3183DonepezilDonepezil
    68071-3192DonepezilDonepezil
    68071-3198DonepezilDonepezil
    68071-4613DonepezilDonepezil
    68071-4615DonepezilDonepezil
    71335-0792DonepezilDonepezil
    31722-737DonepezilDonepezil
    31722-738DonepezilDonepezil
    50090-2627DonepezilDonepezil
    60687-292DonepezilDonepezil
    60687-303DonepezilDonepezil
    68788-7632DonepezilDonepezil
    0143-9747Donepezil HydrochlorideDonepezil Hydrochloride
    0143-9748Donepezil HydrochlorideDonepezil Hydrochloride
    0179-0208DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE
    0228-4529Donepezil hydrochlorideDonepezil hydrochloride
    0378-1025Donepezil Hydrochloridedonepezil hydrochloride
    0615-7623donepezil hydrochlorideDONEPEZIL HYDROCHLORIDE
    0615-7624donepezil hydrochlorideDONEPEZIL HYDROCHLORIDE
    0615-7653Donepezil hydrochlorideDonepezil hydrochloride
    0615-7654Donepezil hydrochlorideDonepezil hydrochloride
    0615-7842Donepezil HydrochlorideDonepezil Hydrochloride
    0615-7843Donepezil HydrochlorideDonepezil Hydrochloride
    0615-7951Donepezil HydrochlorideDonepezil Hydrochloride
    0615-7952Donepezil HydrochlorideDonepezil Hydrochloride
    0615-8313Donepezil HydrochlorideDonepezil Hydrochloride
    0781-5274Donepezil HydrochlorideDonepezil Hydrochloride
    0781-5275Donepezil HydrochlorideDonepezil Hydrochloride
    0781-5276Donepezil Hydrochloridedonepezil hydrochloride
    0781-5277Donepezil Hydrochloridedonepezil hydrochloride
    0904-6408Donepezil HydrochlorideDonepezil Hydrochloride
    0904-6409Donepezil HydrochlorideDonepezil Hydrochloride
    0904-6477Donepezil HydrochlorideDonepezil Hydrochloride
    0904-6478Donepezil HydrochlorideDonepezil Hydrochloride
    13668-102Donepezil HydrochlorideDonepezil Hydrochloride
    13668-103Donepezil HydrochlorideDonepezil Hydrochloride
    16571-778Donepezil HydrochlorideDonepezil Hydrochloride
    16571-779Donepezil HydrochlorideDonepezil Hydrochloride

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