NDC 64239-404

Donepezil Hydrochloride

Donepezil Hydrochloride

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

Product ID64239-404_4881001c-c215-2033-e054-00144ff8d46c
NDC64239-404
Product TypeHuman Prescription Drug
Proprietary NameDonepezil Hydrochloride
Generic NameDonepezil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA203713
Labeler NameDexcel Pharma Technologies Ltd.
Substance NameDONEPEZIL HYDROCHLORIDE
Active Ingredient Strength23 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 64239-404-10

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64239-404-10)
Marketing Start Date2016-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64239-404-50 [64239040450]

Omeprazole Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-01
Inactivation Date2020-01-31

NDC 64239-404-03 [64239040403]

Omeprazole Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-01
Inactivation Date2020-01-31

NDC 64239-404-10 [64239040410]

Omeprazole Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA203713
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-07-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DONEPEZIL HYDROCHLORIDE23 mg/1

OpenFDA Data

SPL SET ID:04498589-1cbb-4008-80ce-f9f1ac57eb86
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1100184
    • UPC Code
  • 0064239404503
  • 0064239404107
  • 0064239404039

    • 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.