NDC 0378-1025

Donepezil Hydrochloride

Donepezil Hydrochloride

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

Product ID0378-1025_ef1015bb-2d5c-4a14-bf0c-8225b87ca1c5
NDC0378-1025
Product TypeHuman Prescription Drug
Proprietary NameDonepezil Hydrochloride
Generic NameDonepezil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA202656
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDONEPEZIL HYDROCHLORIDE
Active Ingredient Strength23 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1025-77

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1025-77)
Marketing Start Date2015-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1025-77 [00378102577]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202656
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-11

NDC 0378-1025-93 [00378102593]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202656
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-11

NDC 0378-1025-05 [00378102505]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202656
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-11
Marketing End Date2017-10-26

Drug Details

Active Ingredients

IngredientStrength
DONEPEZIL HYDROCHLORIDE23 mg/1

OpenFDA Data

SPL SET ID:174fadaa-f1ba-4316-bae4-40ab36c5b6d9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1100184
    • UPC Code
  • 0303781025935

    • Pharmacological Class

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