H 16 Pill — YELLOW OVAL, 6mm — Simvastatin

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ImprintH / 16
ColourYELLOW
ShapeOVAL
Size6
StrengthSIMVASTATIN 5 mg
Dosage formTablet, Film Coated
ManufacturerNuCare Pharmaceuticals, Inc.
NDC68071-3115
Schedule—
Availability—
IngredientsSIMVASTATIN[SIMVASTATIN]

What does this imprint mean?

The imprint "H 16" 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

Simvastatin

Uses and warnings

No boxed warning present. Major safety concerns include: Myopathy/Rhabdomyolysis (risk factors include age >=65, renal impairment, drug interactions; "discontinue simvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected"); Immune-Mediated Necrotizing Myopathy (IMNM), a rare autoimmune condition requiring discontinuation if suspected; Hepatic Dysfunction - "rare reports of fatal and non-fatal hepatic failure have occurred," monitor liver enzymes before and during therapy.

Simvastatin is indicated to: "Reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke" in high-risk patients with established cardiovascular disease or diabetes; lower LDL cholesterol in primary hyperlipidemia and familial hypercholesterolemia; treat hypertriglyceridemia and primary dysbetalipoproteinemia as dietary adjunct.

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How to identify this pill

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 4aa18675-91ae-29b1-e054-00144ff88e88.xml