NDC 42582-311

Donepezil Hyrochloride 5mg

Donepezil Hydrochloride

Donepezil Hyrochloride 5mg is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bi-coastal Pharma International Llc. The primary component is Donepezil Hydrochloride.

Product ID42582-311_dc6e4127-412d-40b6-b313-46d489e7e181
NDC42582-311
Product TypeHuman Prescription Drug
Proprietary NameDonepezil Hyrochloride 5mg
Generic NameDonepezil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA090551
Labeler NameBi-Coastal Pharma International LLC
Substance NameDONEPEZIL HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42582-311-09

90 TABLET, FILM COATED in 1 BOTTLE (42582-311-09)
Marketing Start Date2016-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42582-311-18 [42582031118]

Donepezil Hyrochloride 5mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090551
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-05

NDC 42582-311-30 [42582031130]

Donepezil Hyrochloride 5mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090551
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-05

NDC 42582-311-09 [42582031109]

Donepezil Hyrochloride 5mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090551
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-05

Drug Details

Active Ingredients

IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:6ba90d01-3a96-4780-99df-2b4af8c3ea38
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997229
  • 997223
  • UPC Code
  • 0342582311304
  • 0342582312301
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Donepezil Hyrochloride 5mg" or generic name "Donepezil Hydrochloride"

    NDCBrand NameGeneric Name
    42582-311Donepezil Hyrochloride 5mgDonepezil Hyrochloride 5mg
    62980-504Donepezil Hyrochloride 5mgDonepezil Hyrochloride 5mg
    64380-907Donepezil Hyrochloride 5mgDonepezil Hyrochloride 5mg
    62980-907Donepezil Hyrochloride 5mgDonepezil Hyrochloride 5mg
    62980-908Donepezil Hyrochloride 5mgDonepezil Hyrochloride 5mg
    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

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