B301 10 Pill — ORANGE OVAL, 9mm — Simvastatin
| Imprint | B301 / 10 |
|---|---|
| Colour | ORANGE |
| Shape | OVAL |
| Size | 9 |
| Strength | SIMVASTATIN 10 mg |
| Dosage form | Tablet, Film Coated |
| Manufacturer | Biocon Pharma Inc. |
| NDC | 70377-002 |
| Schedule | — |
| Availability | Prescription only |
| Ingredients | SIMVASTATIN[SIMVASTATIN] |
What does this imprint mean?
The imprint "B301 10" 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.
How to identify this pill
- • Check the imprint matches exactly: "B301 10".
- • Confirm the colour (ORANGE) and shape (OVAL).
- • Compare the size (9) against a ruler if possible.
- • When in doubt, confirm with a pharmacist before taking any medication.
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Official references
Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 4ea81ae0-c11c-fb4b-7d9a-99bcc5e17dfe.xml