RISPERIDONE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)

제공처:

Zydus Lifesciences Limited

INN (국제 이름):

RISPERIDONE

구성:

RISPERIDONE 0.25 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)] . Monotherapy Risperidone is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)] . Adjunctive Therapy Risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)] . Risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing

제품 요약:

Risperidone Tablets USP, 0.25 mg are dark yellow, round, biconvex film-coated tablets debossed with "Z" on one side and "4" on the other side and are supplied as follows: NDC 65841-665-06in bottle of 30 tablets NDC 65841-665-14 in bottle of 60 tablets NDC 65841-665-16 in bottle of 90 tablets NDC 65841-665-01 in bottle of 100 tablets NDC 65841-665-05 in bottle of 500 tablets NDC 65841-665-10 in bottle of 1000 tablets Risperidone Tablets USP, 0.5 mg are red-brown colored, round, biconvex film-coated tablets debossed with "Z" on one side and "6" on other side and are supplied as follows: NDC 65841-666-06 in bottle of 30 tablets NDC 65841-666-14 in bottle of 60 tablets NDC 65841-666-16 in bottle of 90 tablets NDC 65841-666-01 in bottle of 100 tablets NDC 65841-666-05 in bottle of 500 tablets NDC 65841-666-10 in bottle of 1000 tablets Risperidone Tablets USP, 1 mg are white to off-white, round, biconvex film-coated tablets debossed with "ZC 75" on one side and plain on other side and are supplied as follows: NDC 65841-667-06 in bottle of 30 tablets NDC 65841-667-14 in bottle of 60 tablets NDC 65841-667-16 in bottle of 90 tablets NDC 65841-667-01 in bottle of 100 tablets NDC 65841-667-05 in bottle of 500 tablets NDC 65841-667-10 in bottle of 1000 tablets Risperidone Tablets USP, 2 mg are orange, round, biconvex film-coated tablets debossed with "ZC 76" on one side and plain on other side and are supplied as follows: NDC 65841-668-06 in bottle of 30 tablets NDC 65841-668-14 in bottle of 60 tablets NDC 65841-668-16 in bottle of 90 tablets NDC 65841-668-01 in bottle of 100 tablets NDC 65841-668-05 in bottle of 500 tablets NDC 65841-668-10 in bottle of 1000 tablets Risperidone Tablets USP, 3 mg are yellow, round, biconvex film-coated tablets debossed with "ZC 77"on one side and plain on other side and are supplied as follows: NDC 65841-669-06 in bottle of 30 tablets NDC 65841-669-14 in bottle of 60 tablets NDC 65841-669-16 in bottle of 90 tablets NDC 65841-669-01 in bottle of 100 tablets NDC 65841-669-05 in bottle of 500 tablets NDC 65841-669-10 in bottle of 1000 tablets Risperidone Tablets USP, 4 mg are green, round, biconvex film-coated tablets debossed with "ZC 78" on one side and plain on other side and are supplied as follows: NDC 65841-670-06 in bottle of 30 tablets NDC 65841-670-14 in bottle of 60 tablets NDC 65841-670-16 in bottle of 90 tablets NDC 65841-670-01 in bottle of 100 tablets NDC 65841-670-05 in bottle of 500 tablets NDC 65841-670-10 in bottle of 1000 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Keep out of reach of children. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

RISPERIDONE - RISPERIDONE TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
RISPERIDONE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Risperidone Tablets USP, 0.25 mg
NDC 65841-665-14
60 tablets
Rx only
Risperidone Tablets USP, 0.5 mg
NDC 65841-666-14
60 tablets
Rx only
Risperidone Tablets USP, 1 mg
NDC 65841-667-14
60 Tablets
Rx only
Risperidone Tablets USP, 2 mg
NDC 65841-668-14
60 Tablets
Rx only
Risperidone Tablets USP, 3 mg
NDC 65841-669-14
60 Tablets
Rx only
Risperidone Tablets USP, 4 mg
NDC 65841-670-14
60 Tablets
Rx only
RISPERIDONE
risperidone tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-665
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
RISPERIDONE (UNII: L6UH7ZF8HC) (RISPERIDONE - UNII:L6UH7ZF8HC)
RISPERIDONE
0.25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (DARK YELLOW)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
5mm
FLAVOR
IMPRINT CODE
Z ;4
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-665-
06
30 in 1 BOTTLE; Type 0: Not a Combination
Product
11/13/2008
2
NDC:65841-665-
14
60 in 1 BOTTLE; Type 0: Not a Combination
Product
11/13/2008
3
NDC:65841-665-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
11/13/2008
4
NDC:65841-665-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
11/13/2008
5
NDC:65841-665-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
11/13/2008
6
NDC:65841-665-
10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
11/13/2008
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER