Donepezil Hydrochloride (Page 9 of 9)

PRINCIPAL DISPLAY PANEL – 5 mg

NDC 69150-415-03

Donepezil

Tablets, USP

5mg

Rx Only

30 tablets

BIOMES

Donepezil Hydrochloride Tablets 23 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 10 mg

NDC 69150-416-03

Donepezil

Tablets, USP

10mg

Rx Only

30 tablets

BIOMES

image description
(click image for full-size original)
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69150-415
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE (DONEPEZIL) DONEPEZIL HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code V;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69150-415-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:69150-415-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:69150-415-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090551 02/25/2016
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69150-416
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DONEPEZIL HYDROCHLORIDE (DONEPEZIL) DONEPEZIL HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TALC
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow (Pale yellow) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code V;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69150-416-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:69150-416-09 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:69150-416-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090551 02/25/2016
Labeler — BIOMES PHARMACEUTICALS LLC (078644310)
Registrant — BIOMES PHARMACEUTICALS LLC (078644310)

Revised: 05/2018 BIOMES PHARMACEUTICALS LLC

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