NDC 46708-092

Donepezil Hydrochloride 5 mg

Donepezil Hydrochloride

Donepezil Hydrochloride 5 mg is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Donepezil Hydrochloride.

Product ID46708-092_6ca3acff-fe7c-483a-a728-39e06c279dbb
NDC46708-092
Product TypeHuman Prescription Drug
Proprietary NameDonepezil Hydrochloride 5 mg
Generic NameDonepezil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-03-04
Marketing CategoryANDA / ANDA
Application NumberANDA201724
Labeler NameAlembic Pharmaceuticals Limited
Substance NameDONEPEZIL HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 46708-092-91

1000 TABLET, FILM COATED in 1 BOTTLE (46708-092-91)
Marketing Start Date2013-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-092-10 [46708009210]

Donepezil Hydrochloride 5 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201724
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-04
Inactivation Date2020-01-31

NDC 46708-092-30 [46708009230]

Donepezil Hydrochloride 5 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201724
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-04
Inactivation Date2020-01-31

NDC 46708-092-91 [46708009291]

Donepezil Hydrochloride 5 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201724
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-03-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:6ca3acff-fe7c-483a-a728-39e06c279dbb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 997229
  • 997223
    • UPC Code
  • 0346708093303
  • 0346708092306

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    46708-092Donepezil Hydrochloride 5 mgDonepezil Hydrochloride 5 mg
    46708-093Donepezil Hydrochloride 5 mgDonepezil Hydrochloride 5 mg
    55154-6891Donepezil Hydrochloride 5 mgDonepezil Hydrochloride 5 mg
    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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