NDC 68554-5037

Donepezil Hydrochloride

Donepezil Hydrochloride

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

Product ID68554-5037_80cddc08-045b-4321-9e90-e3a649561378
NDC68554-5037
Product TypeHuman Prescription Drug
Proprietary NameDonepezil Hydrochloride
Generic NameDonepezil Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-09-02
Marketing CategoryANDA / ANDA
Application NumberANDA203034
Labeler NameHetero Labs Limited
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 68554-5037-4

10 TABLET, FILM COATED in 1 CARTON (68554-5037-4)
Marketing Start Date2014-09-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68554-5037-0 [68554503700]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-02

NDC 68554-5037-1 [68554503701]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-02

NDC 68554-5037-2 [68554503702]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-02

NDC 68554-5037-3 [68554503703]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-02

NDC 68554-5037-4 [68554503704]

Donepezil Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-02

Drug Details

Active Ingredients

IngredientStrength
DONEPEZIL HYDROCHLORIDE5 mg/1

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

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