DONEPEZIL HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)

Available from:

Zydus Lifesciences Limited

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Composition:

DONEPEZIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Donepezil hydrochloride tablets, USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease. Donepezil hydrochloride tablets are contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Pregnancy Category C There are no adequate or well-controlled studies in pregnant women. Donepezil hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.   Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 20 times the MRHD on a mg/m2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactati

Product summary:

Donepezil Hydrochloride Tablets USP, 5 mg are white to off-white, round-shaped, biconvex film-coated tablets debossed with "ZF9" on one side and plain on other side and are supplied as follows: NDC 65841-749-06 in bottle of 30 tablets NDC 65841-749-16 in bottle of 90 tablets NDC 65841-749-01 in bottle of 100 tablets NDC 65841-749-05 in bottle of 500 tablets NDC 65841-749-10 in bottle of 1000 tablets NDC 65841-749-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Donepezil Hydrochloride Tablets USP, 10 mg are white to off-white, round-shaped, biconvex film-coated tablets debossed with "ZF10" on one side and plain on other side and are supplied as follows: NDC 65841-750-06 in bottle of 30 tablets NDC 65841-750-16 in bottle of 90 tablets NDC 65841-750-01 in bottle of 100 tablets NDC 65841-750-05 in bottle of 500 tablets NDC 65841-750-10 in bottle of 1000 tablets NDC 65841-750-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
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DONEPEZIL HYDROCHLORIDE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-749-01 in bottle of 100 tablets
Donepezil Hydrochloride Tablets USP, 5 mg
R only
100 tablets
NDC 65841-750-01 in bottle of 100 tablets
Donepezil Hydrochloride Tablets USP, 10 mg
R only
100 tablets
x
x
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-749
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL -
UNII:8SSC91326P)
DONEPEZ IL
HYDROCHLORIDE
5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
7mm
FLAVOR
IMPRINT CODE
Z F9
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
749-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
05/25/2011
2
NDC:65841-
749-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
05/25/2011
3
NDC:65841-
749-06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
05/25/2011
4
NDC:65841-
749-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
05/25/2011
5
NDC:65841-
749-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
05/25/2011
6
NDC:65841-
749-30
10 in 1 CARTON
05/25/2011
6
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA090100
05/25/2011
DONEPEZIL