Levocarnitine 1 g/10mL Solution, 118 mL — NDC 52817-830-04 (Billing 52817-0830-04)
This is a package of 118 mL of Levocarnitine 1 g/10mL Solution from TRUPHARMA, LLC, marketed since Feb 2022 and currently FDA-listed; retail pharmacies pay about $0.1450 per mL (NADAC). It is this product's only package size.
Other active recalls for Levocarnitine (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 062733
- GCN: 98507
- GPI-14 (Medi-Span): 30903045102010
- HICL (First Databank): 034794
- AHFS class code: 92:92.00.00
- RxCUI (RxNorm): 315134
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Carnitine Analog class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It replaces carnitine when your body doesn't have enough. That can be from primary carnitine deficiency, an inherited metabolic disorder, or, with the injection, dialysis for end s...
- Tablets and oral solution are taken by mouth, usually a couple of times a day. The oral solution is never to be injected. The injection is given into a vein by your care team. Your...
- Some people have nausea, vomiting, body odor, or an upset stomach. Large doses may cause diarrhea. These are often temporary, but tell your pharmacist or doctor if they bother you.
- Call for emergency help if you have trouble breathing, wheezing, or swelling of your throat after a dose. Also call your doctor if you have a seizure. Seizures have been reported,...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Levocarnitine (prescription drug) — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.145 | $17.11 / 118 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1632 | $19.26 / 118 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.2050 | $24.19 / 118 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 52817-0830-04 You're viewing this Main listing | 118 mL in 1 BOTTLE | 2022-02-09 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levocarnitine 1 g/10mLthis 52817-0830-04 | TRUPHARMA, | 118 ml | $0.145 | AA | Availability likely | — |
| Levocarnitine 1 g/10mL 64980-0503-12 | Rising | 118 ml | $0.145 | AA | Availability likely | — |
| Levocarnitine 1 g/10mL 70954-0139-10 | ANI | 118 ml | $0.145 | AA | Availability likely | — |
| Levocarnitine 1 g/10mL 70954-0140-10 | ANI | 118 ml | $0.252 | AA | Availability likely | +74% |
| Carnitor 1 g/10mL 54482-0145-08 | Leadiant | 24 bottles | $0.332 | AA | FDA listed | +129% |
| Carnitor SF 1 g/10mL 54482-0148-01 | Leadiant | 24 bottles | $0.536 | AA | FDA listed | +269% |
| Levocarnitine 1 g/10mL 71656-0016-01 | Saptalis | 100 cups | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Oct 3, 2026
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 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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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.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Levocarnitine oral solution 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 oral solution is also indicated for the acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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.
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. 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 (30 mL/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 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 postmarketing 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 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 ). To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 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 a 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 acyl-CoA 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 acyl-CoA dehydrogenase deficiency. 7,8 Autointoxication occurs in these patients due to the accumulation of acyl-CoA compounds that disrupt intermediary metabolism. The subsequent hydrolysis of the acyl-CoA compound to its free acid results in acidosis which can be life-threatening.
Levocarnitine clears the acyl-CoA 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 oral solution, USP is a clear colorless solution with cherry flavor, supplied in 118 mL (4 fl. oz.) plastic containers (NDC 52817-830-04). Store at controlled room temperature 15º to 30 ºC (59º to 86º F) [see USP].
📋 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, USP is a white crystalline, hygroscopic powder.
It is freely soluble in water, soluble in warm alcohol, and practically insoluble in acetone. The specific rotation of levocarnitine is between -29° and -32°. Its chemical structure is: Molecular formula: C 7 H 15 NO 3 Molecular weight: 161.20 Each 118 mL container of levocarnitine oral solution, USP contains 1 g of levocarnitine, USP/10 mL.
Also contains: artificial cherry flavor, ethyl alcohol (0.0094%), malic acid, purified water, sucrose. Methylparaben and propylparaben are added as preservatives. The pH is between 4.0 to 6.0. chemical structure
⚠️ Precautions ▾
PRECAUTIONS General Levocarnitine oral solution is for oral/internal use only. Not for parenteral use. Gastrointestinal reactions may result from a too rapid consumption of carnitine.
Levocarnitine oral solution may be consumed alone, or dissolved in drinks or other liquid foods to reduce taste fatigue. They should be consumed slowly and doses should be spaced evenly throughout the day to maximize tolerance. The safety and efficacy of oral levocarnitine have not been evaluated in patients with renal insufficiency.
Chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are normally excreted in the urine. 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity tests performed in Salmonella typhimurium, Saccharomyces cerevisiae, and Schizosaccharomyces pombe indicate that levocarnitine is not mutagenic. No long-term animal studies have been performed to evaluate the carcinogenic potential of levocarnitine. 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. Nursing Mothers Levocarnitine supplementation in nursing mothers has not been specifically studied.
Studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother. Consideration may be given to discontinuation of nursing or of levocarnitine treatment.
Pediatric Use See DOSAGE AND ADMINISTRATION .
🍼 Nursing Mothers ▾
Nursing Mothers Levocarnitine supplementation in nursing mothers has not been specifically studied. Studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine. In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against the benefits of levocarnitine supplementation to the mother.
Consideration may be given to discontinuation of nursing or of levocarnitine treatment.
🧬 Pharmacokinetics ▾
Pharmacokinetics In a relative bioavailability study in 15 healthy adult male volunteers, levocarnitine tablets were found to be bio-equivalent to levocarnitine oral solution. Following 4 days of dosing with 6 tablets of levocarnitine 330 mg b.i.d. or 2 g of levocarnitine oral solution b.i.d., the maximum plasma concentration (C max ) was about 80 µmol/L and the time to maximum plasma concentration (T max ) occurred at 3.3 hours. The plasma concentration profiles of levocarnitine after a slow 3-minute intravenous bolus dose of 20 mg/kg of levocarnitine were described by a two-compartment model.
Following a single i.v. administration, approximately 76% of the levocarnitine dose was excreted in the urine during the 0-24h interval. Using plasma concentrations uncorrected for endogenous levocarnitine, the mean distribution half-life was 0.585 hours and the mean apparent terminal elimination half-life was 17.4 hours. The absolute bioavailability of levocarnitine from the two oral formulations of levocarnitine, calculated after correction for circulating endogenous plasma concentrations of levocarnitine, was 15.1 ± 5.3% for levocarnitine tablets and 15.9 ± 4.9% for levocarnitine oral solution.
Total body clearance of levocarnitine (Dose/AUC including endogenous baseline concentrations) was a mean of
4.00L/h. Levocarnitine was not bound to plasma protein or albumin when tested at any concentration or with any species including the human. 9
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity tests performed in Salmonella typhimurium, Saccharomyces cerevisiae, and Schizosaccharomyces pombe indicate that levocarnitine is not mutagenic. No long-term animal studies have been performed to evaluate the carcinogenic potential of levocarnitine.
📚 References ▾
REFERENCES Bohmer, T., Rydning, A. and Solberg, H.E. 1974. Carnitine levels in human serum in health and disease.
Clin. Chim. Acta 57:55-61.
Brooks, H., Goldberg, L., Holland, R. et al . 1977. Carnitine-induced effects on cardiac and peripheral hemodynamics.
J. Clin. Pharmacol .
17:561-568. Christiansen, R., Bremer, J. 1976.
Active transport of butyrobetaine and carnitine into isolated liver cells. Biochim. Biophys .
Acta 448:562-577. Lindstedt, S. and Lindstedt, G. 1961.
Distribution and excretion of carnitine in the rat. Acta Chem. Scand .
15:701-702. Rebouche, C.J. and Engel, A.G. 1983.
Carnitine metabolism and deficiency syndromes. Mayo Clin. Proc.
58:533-540. Rebouche, C.J. and Paulson, D.J. 1986.
Carnitine metabolism and function in humans. Ann. Rev.
Nutr. 6:41-66. Scriver, C.R., Beaudet, A.L., Sly, W.S. and Valle, D.
1989. The Metabolic Basis of Inherited Disease. New York: McGraw-Hill.
Schaub, J., Van Hoof, F. and Vis, H.L. 1991. Inborn Errors of Metabolism .
New York: Raven Press. Marzo, A., Arrigoni Martelli, E., Mancinelli, A., Cardace, G., Corbelletta, C., Bassani, E. and Solbiati, M. 1991.
Protein binding of L-carnitine family components. Eur. J.
Drug Met. Pharmacokin., Special Issue III: 364-368. Rebouche, C.J.
1991. Quantitative estimation of absorption and degradation of a carnitine supplement by human adults. Metabolism 40:1305-1310.
Manufactured by: Saptalis Pharmaceuticals, LLC Hauppauge, NY 11788 Distributed by: TruPharma, LLC Tampa, FL 33609 MADE IN USA 12/21-R1
📄 Package Label / Principal Display Panel ▾
Package/Label Display Panel NDC 52817-830-04 Levocarnitine Oral Solution, USP 1 g/10 mL Rx only 118 mL (4 fl. oz.) Multiple Unit Container 1 g/10 mL-118 mL (4 fl. oz.)