Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F)
Zydus Lifesciences Limited
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
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 Lue koko asiakirja