CARVEDILOL tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)

Dostupno od:

Zydus Lifesciences Limited

INN (International ime):

CARVEDILOL

Sastav:

CARVEDILOL 3.125 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4) and Clinical Studies (14.1) ]. Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see  Clinical Studies (14.2)]. Carvedilol tablets are indicated for the management of essential hypertension [see  Clinical Studies (14.3, 14.4)] . It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)]. Carvedilol tablets are contraindicated in the following conditions: - Bronchial asthma or related bronchospastic conditions. D

Proizvod sažetak:

Carvedilol Tablets USP, 3.125 mg are white to off-white, round, biconvex, film-coated tablets debossed with 'Z' on one side and '1' on other side  and are supplied as follows: NDC-65841-616-17 in bottles of 28 tablets NDC-65841-616-01 in bottles of 100 tablets NDC-65841-616-05 in bottles of 500 tablets Carvedilol Tablets USP, 6.25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC40' on one side and plain on other side and are supplied as follows: NDC-65841-617-17 in bottles of 28 tablets NDC-65841-617-01 in bottles of 100 tablets NDC-65841-617-05 in bottles of 500 tablets Carvedilol Tablets USP, 12.5 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC41' on one side and plain on other side and are supplied as follows: NDC-65841-618-17 in bottles of 28 tablets NDC-65841-618-01 in bottles of 100 tablets NDC-65841-618-05 in bottles of 500 tablets Carvedilol Tablets USP, 25 mg are white to off-white, round, biconvex, beveled edge, film-coated tablets debossed with 'ZC42' on one side and plain on other side and are supplied as follows: NDC-65841-619-17 in bottles of 28 tablets NDC-65841-619-01 in bottles of 100 tablets NDC-65841-619-05 in bottles of 500 tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CARVEDILOL - CARVEDILOL TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
CARVEDILOL TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-616-01 in bottle of 100 Tablets
Carvedilol Tablets USP, 3.125 mg
R only
100 Tablets
NDC 65841-617-01 in bottle of 100 Tablets
Carvedilol Tablets USP, 6.25 mg
R only
100 Tablets
x
x
NDC 65841-618-01 in bottle of 100 Tablets
Carvedilol Tablets USP, 12.5 mg
R only
100 Tablets
NDC 65841-619-01 in bottle of 100 Tablets
Carvedilol Tablets USP, 25 mg
R only
100 Tablets
x
x
CARVEDILOL
carvedilol tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-616
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2)
CARVEDILOL
3.125 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
4mm
FLAVOR
IMPRINT CODE
Z ;1
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-616-
17
28 in 1 BOTTLE; Type 0: Not a Combination
Product
09/05/2007
2
NDC:65841-616-
01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
09/05/2007
3
NDC:65841-616-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
09/05/2007
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA077614
09/05/2007
CARVEDILOL
carvedilol tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-617
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NA