630 Pill — PURPLE OVAL, 16mm — Rosuvastatin

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Imprint630
ColourPURPLE
ShapeOVAL
Size16
StrengthROSUVASTATIN CALCIUM 40 mg
Dosage formTablet, Film Coated
ManufacturerCadila Healthcare Limited
NDC70771-1484
Schedule—
Availability—
IngredientsROSUVASTATIN CALCIUM[ROSUVASTATIN]

What does this imprint mean?

The imprint "630" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Rosuvastatin

Uses and warnings

No boxed warning. Contraindications: "acute liver failure or decompensated cirrhosis" and "hypersensitivity to rosuvastatin or any excipients." Key warnings cover myopathy/rhabdomyolysis, with risk factors including "age 65 years or greater, uncontrolled hypothyroidism, renal impairment" - patients should report "unexplained muscle pain, tenderness, or weakness"; hepatic dysfunction, with "increases in serum transaminases" and rare "fatal and non-fatal hepatic failure"; and rare immune-mediated necrotizing myopathy (IMNM) associated with statin use.

Rosuvastatin is indicated to "reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures" in adults without established coronary heart disease who have elevated risk, to reduce LDL-C "as an adjunct to diet" in adults with primary hyperlipidemia, to "slow the progression of atherosclerosis," to reduce LDL-C in pediatric patients 8+ with heterozygous familial hypercholesterolemia (HeFH) and 7+ with homozygous FH (HoFH), and to treat primary dysbetalipoproteinemia and hypertriglyceridemia in adults.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 493a5304-a54c-41db-80b8-b2f25f09d829.xml