Levocarnitine 1 g/10mL Solution, 118 mL
Other active recalls for Levocarnitine (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Carnitine Analog class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Levocarnitine is a substance your body normally makes and gets from food — especially meat and dairy — that helps your cells burn fat for energy. Your doctor has likely prescribed...
- What exactly is levocarnitine and why has my doctor prescribed it?
- The most common side effects are nausea, vomiting, diarrhea, and stomach discomfort — these are usually manageable and may ease over time. You might also notice a fishy body odor,...
- What side effects should I expect, and when should I actually call my doctor?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Levocarnitine (prescription drug) — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII BUC5I9595W
A natural flavoring derived from cherry fruit that gives the medicine its cherry taste. It helps mask bitter drug flavors and makes the medication more pleasant to take.
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UNII 817L1N4CKP
Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.139 | $16.37 / 118 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1667 | $19.67 / 118 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.2050 | $24.19 / 118 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levocarnitine 1 g/10mL 52817-0830-04 | TRUPHARMA, | 118 ml | $0.139 | AA | Availability likely | — |
| Levocarnitine 1 g/10mL 64980-0503-12 | Rising | 118 ml | $0.139 | AA | Availability likely | — |
| Levocarnitine 1 g/10mLthis 70954-0139-10 | ANI | 118 ml | $0.139 | AA | Availability likely | — |
| Levocarnitine 1 g/10mL 70954-0140-10 | ANI | 118 ml | $0.254 | AA | Availability likely | +83% |
| Carnitor 1 g/10mL 54482-0145-08 | Leadiant | 24 bottles | $0.332 | AA | FDA listed | +139% |
| Carnitor SF 1 g/10mL 54482-0148-01 | Leadiant | 24 bottles | $0.536 | AA | FDA listed | +286% |
| Levocarnitine 1 g/10mL 71656-0016-01 | Saptalis | 100 cups | — | AA | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70954-0139-10 You're viewing this | 118 mL in 1 BOTTLE (70954-139-10) | 2019-08-14 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE 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 cell and/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.
⏱️ Dosage and Administration ▾
DOSAGE & ADMINISTRATION Levocarnitine Tablets. Adults: The recommended oral dosage for adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response. Infants and children: The recommended oral dosage for infants and children is between 50 and 100 mg/kg/day in divided doses, with a maximum of 3 g/day.
Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.
Levocarnitine Oral Solution and Levocarnitine Oral Solution (Sugar Free). For oral use only. Not for parenteral use.
Adults: The recommended dosage of levocarnitine is 1 to 3 g/day for a 50 kg subject, which is equivalent to 10 to 30 mL/day of Levocarnitine Oral Solution or Levocarnitine Oral Solution (Sugar Free). Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 1 g/day, (10 mL/day), and be increased slowly while assessing tolerance and therapeutic response.
Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition. Infants and children: The recommended dosage of levocarnitine is 50 to 100 mg/kg/day which is equivalent to 0.5 mL/kg/day Levocarnitine Oral Solution or Levocarnitine Oral Solution (Sugar Free). Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit.
Dosage should start at 50 mg/kg/day, and be increased slowly to a maximum of 3 g/day (30mL/day) while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition. Levocarnitine Oral Solution or Levocarnitine Oral Solution (Sugar Free) may be consumed alone or dissolved in drink or other liquid food.
Doses should be spaced evenly throughout the day (every three or four hours) preferably during or following meals and should be consumed slowly in order to maximize tolerance.
⛔ Contraindications ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
WARNINGS Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral Levocarnitine. Other serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following intravenous levocarnitine administration, mostly in patients with end stage renal disease undergoing dialysis. Discontinue use of Levocarnitine and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions associated with the use of oral formulations of levocarnitine were identified in clinical trials or post-marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliability, or to establish a causal relationship to drug exposure. Gastrointestinal Reactions: Various mild gastrointestinal complaints have been reported during the long-term administration of oral L- or D,L-carnitine; these include transient nausea and vomiting, abdominal cramps, and diarrhea.
Gastrointestinal adverse reactions with Levocarnitine Oral Solution or Levocarnitine Oral Solution (Sugar Free) dissolved in liquids might be avoided by a slow consumption of the solution or by a greater dilution. Decreasing the dosage often diminishes or eliminates drug-related patient body odor or gastrointestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration, and after any dosage increases.
Musculoskeletal Reactions : Mild myasthenia has been described only in uremic patients receiving D,L-carnitine. Neurologic Reactions : Seizures have been reported to occur in patients with or without pre-existing seizure activity receiving either oral or intravenous levocarnitine. In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported.
Hypersensitivity Reactions : Rash, urticaria, and facial edema have been reported with oral levocarnitine (see WARNINGS ).
🔄 Drug Interactions ▾
DRUG INTERACTIONS Reports of INR increase with the use of warfarin have been observed. It is recommended that INR levels be monitored in patients on warfarin therapy after the initiation of treatment with levocarnitine or after dose adjustments.
🤰 Pregnancy ▾
PREGNANCY Reproductive studies have been performed in rats and rabbits at doses up to 3.8 times the human dose on the basis of surface area and have revealed no evidence of impaired fertility or harm to the fetus due to Levocarnitine. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
PEDIATRIC USE See DOSAGE AND ADMINISTRATION .
🆘 Overdosage ▾
OVERDOSAGE There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. The intravenous LD 50 of levocarnitine in rats is 5.4 g/kg and the oral LD 50 of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Levocarnitine is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids are utilized as an energy substrate in all tissues except the brain.
In skeletal and cardiac muscle, fatty acids are the main substrate for energy production. Primary systemic carnitine deficiency is characterized by low concentrations of levocarnitine in plasma, RBC, and/or tissues. It has not been possible to determine which symptoms are due to carnitine deficiency and which are due to an underlying organic acidemia, as symptoms of both abnormalities may be expected to improve with Levocarnitine.
The literature reports that carnitine can promote the excretion of excess organic or fatty acids in patients with defects in fatty acid metabolism and/or specific organic acidopathies that bioaccumulate acylCoA esters. 1-6 Secondary carnitine deficiency can be a consequence of inborn errors of metabolism. Levocarnitine may alleviate the metabolic abnormalities of patients with inborn errors that result in accumulation of toxic organic acids.
Conditions for which this effect has been demonstrated are: glutaric aciduria II, methyl malonic aciduria, propionic acidemia, and medium chain fatty acylCoA dehydrogenase deficiency. 7,8 Autointoxication occurs in these patients due to the accumulation of acylCoA compounds that disrupt intermediary metabolism. The subsequent hydrolysis of the acylCoA compound to its free acid results in acidosis which can be life-threatening.
Levocarnitine clears the acylCoA compound by formation of acylcarnitine, which is quickly excreted. Carnitine deficiency is defined biochemically as abnormally low plasma concentrations of free carnitine, less than 20 µmol/L at one week post term and may be associated with low tissue and/or urine concentrations. Further, this condition may be associated with a plasma concentration ratio of acylcarnitine/levocarnitine greater than 0.4 or abnormally elevated concentrations of acylcarnitine in the urine.
In premature infants and newborns, secondary deficiency is defined as plasma levocarnitine concentrations below age-related normal concentrations.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Levocarnitine Tablets, USP are supplied as 330 mg white to off white, round, standard biconvex, uncoated tablets debossed with N492 on one side and plain on the other side in individual blisters, packaged in boxes of 90 (NDC 70954-492-10). Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Levocarnitine Oral Solution, USP is a clear cherry flavored solution supplied in 118 mL (4 fl. oz.) amber colored HDPE bottles (NDC 70954-139-10).
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Levocarnitine Oral Solution, USP (Sugar Free) is a clear cherry flavored solution supplied in 118 mL (4 fl. oz.) white colored HDPE bottles (NDC 70954-140-10). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
Rx only
📋 Description ▾
DESCRIPTION Levocarnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The chemical name of levocarnitine is 3-carboxy-2( R )-hydroxy-N, N, N-trimethyl-1-propanaminium, inner salt. Levocarnitine is a white crystalline, hygroscopic powder.
It is readily soluble in water, hot alcohol, and insoluble in acetone. The specific rotation of levocarnitine is between -29° and -32°. Its chemical structure is: Empirical Formula: C 7 H 15 NO 3 Molecular Weight: 161.20 Each Levocarnitine Tablet, USP for oral use contains 330 mg of levocarnitine and the inactive ingredients Magnesium Stearate, Microcrystalline Cellulose and Povidone.
Each 118 mL container of Levocarnitine Oral Solution, USP contains 1 g of levocarnitine/10 mL. Also contains: Artificial Cherry Flavor, D,L,-Malic Acid, Purified Water, Sucrose Syrup. Methylparaben NF and Propylparaben NF are added as preservatives.
The pH is approximately 5. Each 118 mL container of Levocarnitine Oral Solution, USP (Sugar Free) contains 1 g of levocarnitine/10 mL. Also contains: Artificial Cherry Flavor, D,L,-Malic Acid, Purified Water, Sodium Saccharin USP.
Methylparaben NF and Propylparaben NF are added as preservatives. The pH is approximately 5. FDA approved dissolution test specifications differ from USP.
Levocarnitine-structure