NDC 42582-312

Donepezil Hydrochloride 10mg

Donepezil Hydrochloride

Donepezil Hydrochloride 10mg 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 ID42582-312_dc6e4127-412d-40b6-b313-46d489e7e181
NDC42582-312
Product TypeHuman Prescription Drug
Proprietary NameDonepezil Hydrochloride 10mg
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 Strength10 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42582-312-09

90 TABLET, FILM COATED in 1 BOTTLE (42582-312-09)
Marketing Start Date2016-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42582-312-18 [42582031218]

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

NDC 42582-312-30 [42582031230]

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

NDC 42582-312-09 [42582031209]

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

Drug Details

Active Ingredients

IngredientStrength
DONEPEZIL HYDROCHLORIDE10 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 Hydrochloride 10mg" or generic name "Donepezil Hydrochloride"

    NDCBrand NameGeneric Name
    42582-312Donepezil Hydrochloride 10mgDonepezil Hydrochloride 10mg
    62980-505Donepezil Hydrochloride 10mgDonepezil Hydrochloride 10mg
    64380-908Donepezil Hydrochloride 10mgDonepezil Hydrochloride 10mg
    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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