FDA label
What is levocarnitine used for?
The FDA-approved uses of levocarnitine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.”
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Levocarnitine, injection, solution
Indications and Usage, quoted from the label by Gland Pharma Limited (ANDA220181). Cross-references to other label sections are left out.
For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.
For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
Source: DailyMed label, set id 2685d8da-010e-40d7-914f-80546634888d, version 3, effective October 1, 2026. NDC 68083-681, one of 5 listings for this product.
Levocarnitine, solution
Indications and Usage, quoted from the label by ANI Pharmaceuticals, Inc. (ANDA211676). Cross-references to other label sections are left out.
Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red celland/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
Levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
Source: DailyMed label, set id 18dc8eae-56c1-46ec-9d21-e17d7b2f91db, version 7, effective December 30, 2025. NDC 70954-139, one of 5 listings for this product.
Questions
What is levocarnitine used for?
The FDA label says: “For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.”
What drug class is levocarnitine?
FDA lists levocarnitine in the Carnitine Analog established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.