PRAVASTATIN SODIUM tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)

Boleh didapati daripada:

Zydus Lifesciences Limited

INN (Nama Antarabangsa):

PRAVASTATIN SODIUM

Komposisi:

PRAVASTATIN SODIUM 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablet, USP is indicated to: -   reduce the risk of myocardial infarction (MI). -   reduce the risk of undergoing myocardial revascularization procedures. -   reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. In patients with clinically evident CHD, pravastatin sodium tablet is indicated to: -   reduce the risk of total mortality by reducing coronary death. -   reduce the risk of MI. -   reduce the risk of undergoing myocardial revascularization procedures. -  

Ringkasan produk:

Pravastatin Sodium Tablets USP, 10 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC46' on one side and plain on the other side and are supplied as follows: NDC 65841-739-16 in bottles of 90 tablets NDC 65841-739-05 in bottles of 500 tablets Pravastatin Sodium Tablets USP, 20 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC45' on one side and plain on the other side and are supplied as follows: NDC 65841-740-16 in bottles of 90 tablets NDC 65841-740-05 in bottles of 500 tablets NDC 65841-740-10 in bottles of 1000 tablets Pravastatin Sodium Tablets USP, 40 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC44' on one side and plain on the other side and are supplied as follows: NDC 65841-741-16 in bottles of 90 tablets NDC 65841-741-05 in bottles of 500 tablets Pravastatin Sodium Tablets USP, 80 mg are white to off-white, oval-shaped, biconvex uncoated tablets debossed with the logo of 'ZC43' on one side and plain on the other side and are supplied as follows: NDC 65841-742-16 in bottles of 90 tablets NDC 65841-742-05 in bottles of 500 tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Zydus Lifesciences Limited
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Revised: 10/2022
Document Id: 06a7213c-2672-47ba-86ec-58754a44504d
34391-3
Set id: 187997be-2dbf-40af-885f-16df6ba9ae46
Version: 10
Effective Time: 20221013
Zydus Lifesciences Limited

Ciri produk

PRAVASTATIN SODIUM - PRAVASTATIN SODIUM TABLET
ZYDUS LIFESCIENCES LIMITED
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PRAVASTATIN SODIUM TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-739-05 in bottle of 500 tablets
Pravastatin Sodium Tablets USP, 10 mg
R only
500 tablets
NDC 65841-740-05 in bottle of 500 tablets
Pravastatin Sodium Tablets USP, 20 mg
R only
500 tablets
x
x
NDC 65841-741-05 in bottle of 500 tablets
Pravastatin Sodium Tablets USP, 40 mg
R only
500 tablets
x
NDC 65841-742-05 in bottle of 500 tablets
Pravastatin Sodium Tablets USP, 80 mg
R only
500 tablets
x
PRAVASTATIN SODIUM
pravastatin sodium tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-739
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:KXO2KT9N0G)
PRAVASTATIN SODIUM
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
SODIUM CARBONATE (UNII: 45P3261C7T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
OVAL (OVAL)
SIZE
9mm
FLAVOR
IMPRINT CODE
Z C46
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-739-
16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
03/30/2010
2
NDC:65841-739-
05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
03/30/2010
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA077751
03/30/2010
PRAVASTATIN SODIUM
pravastatin sodium tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-740
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
PRAVASTATIN SODIUM (UNII: 3M8608UQ61) (PRAVASTATIN - UNII:K