NDC 57237-193

Donepezil Hydrochloride

Donepezil Hydrochloride

Donepezil Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Citron Pharma Llc. The primary component is Donepezil Hydrochloride.

Product ID57237-193_5fc06788-5c30-40fc-bab0-382173f99ed4
NDC57237-193
Product TypeHuman Prescription Drug
Proprietary NameDonepezil Hydrochloride
Generic NameDonepezil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA090056
Labeler NameCitron Pharma LLC
Substance NameDONEPEZIL HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 57237-193-05

500 TABLET, FILM COATED in 1 BOTTLE (57237-193-05)
Marketing Start Date2011-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57237-193-99 [57237019399]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090056
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Marketing End Date2019-04-18

NDC 57237-193-30 [57237019330]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090056
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Marketing End Date2019-04-18

NDC 57237-193-05 [57237019305]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090056
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Marketing End Date2019-04-18

NDC 57237-193-90 [57237019390]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090056
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Marketing End Date2019-04-18

Drug Details

Active Ingredients

IngredientStrength
DONEPEZIL HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:4576e381-1e80-4edb-a176-f8f4c1cc0828
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997229
  • 997223
  • UPC Code
  • 0357237192306
  • 0357237193303
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    68071-1572donepezil hydrochloridedonepezil hydrochloride
    68071-1523donepezil hydrochloridedonepezil hydrochloride
    68071-1700donepezil hydrochloridedonepezil hydrochloride
    68071-4008Donepezil HydrochlorideDonepezil Hydrochloride
    68071-3396donepezil hydrochloridedonepezil hydrochloride
    68151-3114Donepezil HydrochlorideDonepezil Hydrochloride
    68180-527DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE
    68382-347donepezil hydrochloridedonepezil hydrochloride
    68382-521donepezil hydrochloridedonepezil hydrochloride
    68382-303donepezil hydrochloridedonepezil hydrochloride
    68382-346donepezil hydrochloridedonepezil hydrochloride
    68382-302donepezil hydrochloridedonepezil hydrochloride
    69150-415Donepezil HydrochlorideDonepezil Hydrochloride
    69150-416Donepezil HydrochlorideDonepezil Hydrochloride
    70518-0452donepezil hydrochloridedonepezil hydrochloride
    70518-0802Donepezil HydrochlorideDonepezil Hydrochloride
    70518-1445Donepezil HydrochlorideDonepezil Hydrochloride
    70518-1666donepezil hydrochloridedonepezil hydrochloride
    70771-1320donepezil hydrochloridedonepezil hydrochloride
    71209-020DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE
    71335-0416Donepezil HydrochlorideDonepezil Hydrochloride
    71209-019DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE
    71335-0582Donepezil HydrochlorideDonepezil Hydrochloride
    71335-0876Donepezil HydrochlorideDonepezil Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.