DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Zydus Lifesciences Limited

ІПН (Міжнародна Ім'я):

DONEPEZIL HYDROCHLORIDE

Склад:

DONEPEZIL HYDROCHLORIDE 5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Donepezil hydrochloride orally disintegrating 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 orally disintegrating 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 du

Огляд продуктів:

Donepezil Hydrochloride Orally disintegrating Tablets USP, 5 mg are white to off-white, round-shaped, biconvex, uncoated tablets engraved with 'ZF 14'on one side and plain on other side and are supplied as follows: NDC 65841-721-06 in bottle of 30 tablets NDC 65841-721-16 in bottle of 90 tablets NDC 65841-721-01 in bottle of 100 tablets NDC 65841-721-05 in bottle of 500 tablets NDC 65841-721-10 in bottle of 1000 tablets NDC 65841-721-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Donepezil Hydrochloride Orally Disintegrating Tablets USP, 10 mg are white to off-white, round-shaped, biconvex, uncoated tablets engraved with 'ZF 15'on one side and plain on other side and are supplied as follows: NDC 65841-722-06 in bottle of 30 tablets NDC 65841-722-16 in bottle of 90 tablets NDC 65841-722-01 in bottle of 100 tablets NDC 65841-722-05 in bottle of 500 tablets NDC 65841-722-10 in bottle of 1000 tablets NDC 65841-722-77 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.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, ORALLY
DISINTEGRATING
ZYDUS LIFESCIENCES LIMITED
----------
DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-721-06 in bottle of 30 tablets
Donepezil Hydrochloride Orally Disintegrating Tablets USP, 5 mg
R only
30 tablets
NDC 65841-722-06 in bottle of 30 tablets
Donepezil Hydrochloride Orally Disintegrating Tablets USP, 10 mg
R only
30 tablets
x
x
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride tablet, orally disintegrating
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-721
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
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
PEPPERMINT (UNII: V95R5KMY2B)
STRAWBERRY (UNII: 4J2TY8Y81V)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF WHITE)
SCORE
no
s core
SHAPE
ROUND (ROUND)
SIZE
7mm
FLAVOR
PEPPERMINT (flavor firmenich powder peppermint) , STRAWBERRY (flavor
s trawberry)
IMPRINT
CODE
Z F;14
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
721-06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
05/11/2011
2
NDC:65841-
721-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
05/11/2011
3
NDC:65841-
721-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
05/11/2011
4
NDC:65841-
721-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
05/11/2011
5
NDC:65841-
721-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
05/11/2011
6
NDC:65841-
721-30
10 in 1 CARTON
05/11/2011
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
AN