ATORVASTATIN CALCIUM tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)

Disponível em:

Zydus Lifesciences Limited

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 recommended 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 patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - Reduce the risk of myocardial infarction - Reduce the risk of stroke - Reduce the risk for revascularization procedures and angina In adult patients with type 2 diabetes, and without clinically evident coronary heart disease

Resumo do produto:

Atorvastatin Calcium Tablets, USP 10 mg are white to off-white, oval-shaped, beveled, biconvex, film-coated tablets debossed with '249' on one side and plain on other side and are supplied as follow: NDC 70771-1443-3 in bottle of 30 tablets NDC 70771-1443-9 in bottle of 90 tablets NDC 70771-1443-1 in bottle of 100 tablets NDC 70771-1443-5 in bottle of 500 tablets NDC 70771-1443-0 in bottle of 1000 tablets NDC 70771-1443-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Atorvastatin Calcium Tablets, USP 20 mg are white to off-white, oval-shaped, beveled, biconvex, film-coated tablets debossed with '250' on one side and plain on other side and are supplied as follow: NDC 70771-1444-3 in bottle of 30 tablets NDC 70771-1444-9 in bottle of 90 tablets NDC 70771-1444-1 in bottle of 100 tablets NDC 70771-1444-5 in bottle of 500 tablets NDC 70771-1444-0 in bottle of 1000 tablets NDC 70771-1444-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Atorvastatin Calcium Tablets, USP 40 mg are white to off-white, oval-shaped, beveled, biconvex, film-coated tablets debossed with '251' on one side and plain on other side and are supplied as follow: NDC 70771-1445-3 in bottle of 30 tablets NDC 70771-1445-9 in bottle of 90 tablets NDC 70771-1445-1 in bottle of 100 tablets NDC 70771-1445-5 in bottle of 500 tablets NDC 70771-1445-0 in bottle of 1000 tablets NDC 70771-1445-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Atorvastatin Calcium Tablets, USP 80 mg are white to off-white, oval-shaped, beveled, biconvex, film-coated tablets debossed with '252' on one side and plain on other side and are supplied as follow: NDC 70771-1446-3 in bottle of 30 tablets NDC 70771-1446-9 in bottle of 90 tablets NDC 70771-1446-1 in bottle of 100 tablets NDC 70771-1446-5 in bottle of 500 tablets NDC 70771-1446-0 in bottle of 1000 tablets NDC 70771-1446-4 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].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ATORVASTATIN CALCIUM - ATORVASTATIN CALCIUM TABLET
ZYDUS LIFESCIENCES LIMITED
----------
ATORVASTATIN CALCIUM TABLETS.
NDC 70771-1443-3
Atorvastatin Calcium Tablets, USP 10 mg
Rx Only
30 Tablets
NDC 70771-1444-3
Atorvastatin Calcium Tablets, USP 20 mg
Rx Only
30 Tablets
NDC 70771-1445-3
Atorvastatin Calcium Tablets, USP 40 mg
Rx Only
30 Tablets
NDC 70771-1446-3
Atorvastatin Calcium Tablets, USP 80 mg
Rx Only
30 Tablets
ATORVASTATIN CALCIUM
atorvastatin calcium tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1443
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN -
UNII:A0JWA85V8F)
ATORVASTATIN
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (white to off-white)
SCORE
no score
SHAPE
OVAL (OVAL)
SIZE
9mm
FLAVOR
IMPRINT CODE
249
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1443-4
10 in 1 CARTON
11/21/2018
1
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
2
NDC:70771-
1443-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
11/21/2018
3
NDC:70771-
1443-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
11/21/2018
4
NDC:70771-
1443-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
11/21/2018
5
NDC:70771-
1443-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
11/21/2018
6
NDC:70771-
1443-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
11/21/2018
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONO