LEVOCARNITINE 1 g/5mL Injection, Solution
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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🧪 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 QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
3 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.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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levocarnitine 1 g/5mL 00143-9852-10 | Hikma | 10 vials | — | AP | FDA listed | — |
| Carnitor 1 g/5mL 54482-0147-01 | Leadiant | 5 vials | — | AP | FDA listed | — |
| levocarnitine 1 g/5mL 73043-0034-05 | Devatis | 5 vials | — | AP | FDA listed | — |
| Levocarnitine 1 g/5mLthis 36000-0368-10 | Baxter | 10 vials | — | AP | 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?
📊 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 |
|---|---|---|---|
| 36000-0368-10 You're viewing this | 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-368-10) / 5 mL in 1 VIAL, SINGLE-DOSE (36000-368-01) | 2026-07-02 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Levocarnitine injection is administered intravenously. Metabolic Disorders The recommended dose is 50 mg/kg given as a slow 2 to 3 minute bolus injection or by infusion. Often a loading dose is given in patients with severe metabolic crisis, followed by an equivalent dose over the following 24 hours.
It should be administered q3h or q4h, and never less than q6h either by infusion or by intravenous injection. All subsequent daily doses are recommended to be in the range of 50 mg/kg or as therapy may require. The highest dose administered has been 300 mg/kg.
It is recommended that a plasma carnitine concentration be obtained prior to beginning this parenteral therapy. Weekly and monthly monitoring is recommended as well. This monitoring should include blood chemistries, vital signs, plasma carnitine concentrations (the plasma free carnitine concentration should be between 35 and 60 µmol/L) and overall clinical condition.
ESRD Patients on Hemodialysis The recommended starting dose is 10 mg/kg to 20 mg/kg dry body weight as a slow 2 to 3 minute bolus injection into the venous return line after each dialysis session. Initiation of therapy may be prompted by trough (pre-dialysis) plasma levocarnitine concentrations that are below normal (40 µmol/L to 50 µmol/L). Dose adjustments should be guided by trough (pre-dialysis) levocarnitine concentrations, and downward dose adjustments (e.g., to 5 mg/kg after dialysis) may be made as early as the third or fourth week of therapy.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. COMPATIBILITY AND STABILITY Levocarnitine injection is compatible and stable when mixed in parenteral solutions of Sodium Chloride 0.9% or Lactated Ringer's in concentrations ranging from 250 mg/500 mL (0.5 mg/mL) to 4200 mg/500 mL (8 mg/mL) and stored at room temperature (25°C) for up to 24 hours in PVC plastic bags.
⛔ Contraindications ▾
CONTRAINDICATIONS None known.
⚠️ Warnings ▾
WARNINGS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following levocarnitine injection administration, mostly in patients with end stage renal disease who are undergoing dialysis. Some reactions occurred within minutes after intravenous administration of levocarnitine injection. If a severe hypersensitivity reaction occurs, discontinue levocarnitine injection treatment and initiate appropriate medical treatment.
Consider the risks and benefits of re-administering levocarnitine injection to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Trials Experience Transient nausea and vomiting have been observed. Less frequent adverse reactions are body odor, nausea, and gastritis. An incidence for these reactions is difficult to estimate due to the confounding effects of the underlying pathology.
The table below lists the adverse events that have been reported in two double-blind, placebo- controlled trials in patients on chronic hemodialysis. Events occurring at ≥5% are reported without regard to causality. Adverse Events with a Frequency ≥5% Regardless of Causality by Body System Placebo (n=63) Levocarnitine 10 mg (n=34) Levocarnitine 20 mg (n=62) Levocarnitine 40 mg (n=34) Levocarnitine 10, 20 & 40 mg (n=130) Body as Whole Abdominal pain 17 21 5 6 9 Accidental injury 10 12 8 12 10 Allergic reaction 5 6 2 Asthenia 8 9 8 12 9 Back pain 10 9 8 6 8 Chest pain 14 6 15 12 12 Fever 5 6 5 12 7 Flu syndrome 40 15 27 29 25 Headache 16 12 37 3 22 Infection 17 15 10 24 15 Injection site reaction 59 38 27 38 33 Pain 49 21 32 35 30 Cardiovascular Arrhythmia 5 3 3 2 Atrial fibrillation 2 6 2 Cardiovascular disorder 6 3 5 6 5 Electrocardiogram abnormal 3 6 2 Hemorrhage 6 9 2 3 4 Hypertension 14 18 21 21 20 Hypotension 19 15 19 3 14 Palpitations 3 8 5 Tachycardia 5 6 5 9 6 Vascular disorder 2 2 6 2 Digestive Anorexia 3 3 5 6 5 Constipation 6 3 3 3 3 Diarrhea 19 9 10 35 16 Dyspepsia 10 9 6 5 Gastrointestinal disorder 2 3 6 2 Melena 3 6 2 Nausea 10 9 5 12 8 Stomach atony 5 Vomiting 16 9 16 21 15 Endocrine System Parathyroid disorder 2 6 2 6 4 Hemic/Lymphatic Anemia 3 3 5 12 6 Metabolic/Nutritional Hypercalcemia 3 15 8 6 9 Hyperkalemia 6 6 6 6 6 Hypervolemia 17 3 3 12 5 Peripheral edema 3 6 5 3 5 Weight decrease 3 3 8 3 5 Weight increase 2 3 6 2 Musculo-Skeletal Leg cramps 13 8 4 Myalgia 6 Nervous Anxiety 5 2 1 Depression 3 6 5 6 5 Dizziness 11 18 10 15 13 Drug dependence 2 6 2 Hypertonia 5 3 1 Insomnia 6 3 6 4 Paresthesia 3 3 3 12 5 Vertigo 6 2 Respiratory Bronchitis 5 3 3 Cough increase 16 10 18 9 Dyspnea 19 3 11 3 7 Pharyngitis 33 24 27 15 23 Respiratory disorder 5 Rhinitis 10 6 11 6 9 Sinusitis 5 2 3 2 Skin And Appendages Pruritus 13 8 3 5 Rash 3 5 3 3 Special Senses Amblyopia 2 6 3 Eye disorder 3 6 3 3 Taste perversion 2 9 3 Urogenital Urinary tract infect 6 3 3 2 Kidney failure 5 6 6 6 6 Postmarketing Experience The following adverse reactions have been reported: 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 : Anaphylaxis, laryngeal edema and bronchospasm (see WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-877-725-2747 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 injection. 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 injection 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 injection.
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 or iatrogenic factors such as hemodialysis. Levocarnitine injection 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. End Stage Renal Disease (ESRD) patients on maintenance hemodialysis may have low plasma carnitine concentrations and an increased ratio of acylcarnitine/carnitine because of reduced intake of meat and dairy products, reduced renal synthesis and dialytic losses. Certain clinical conditions common in hemodialysis patients such as malaise, muscle weakness, cardiomyopathy and cardiac arrhythmias may be related to abnormal carnitine metabolism.
Pharmacokinetic and clinical studies with levocarnitine injection have shown that administration of levocarnitine to ESRD patients on hemodialysis results in increased plasma levocarnitine concentrations.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Levocarnitine injection USP, 200 mg/mL is supplied as single-dose vial available in following strength and pack size: Strength Packaging Configuration NDC Number 1 gm/5 mL (200 mg/mL) 10 x 5 mL single-dose vials per carton 36000-368-10 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.
Discard any unused portion of an opened vial, as the formulation does not contain a preservative. Rx only. REFERENCES 1.
Bohmer, T., Rydning, A. and Solberg, H.E. 1974. Carnitine levels in human serum in health and disease.
Clin. Chim. Acta 57:55-61.
2. Brooks, H., Goldberg, L., Holland, R. et al. 1977.
Carnitine-induced effects on cardiac and peripheral hemodynamics. J. Clin.
Pharmacol. 17:561-568. 3.
Christiansen, R., Bremer, J. 1976. Active transport of butyrobetaine and carnitine into isolated liver cells.
Biochim. Biophys. Acta 448:562-577.
4. Lindstedt, S. and Lindstedt, G. 1961.
Distribution and excretion of carnitine in the rat. Acta Chem. Scand.
15:701-702. 5. Rebouche, C.J. and Engel, A.G.
1983. Carnitine metabolism and deficiency syndromes. Mayo Clin.
Proc. 58:533-540. 6.
Rebouche, C.J. and Paulson, D.J. 1986. Carnitine metabolism and function in humans.
Ann. Rev. Nutr.
6:41-66. 7. Scriver, C.R., Beaudet, A.L., Sly, W.S. and Valle, D.
1989. The Metabolic Basis of Inherited Disease. New York: McGraw-Hill.
8. Schaub, J., Van Hoof, F. and Vis, H.L. 1991.
Inborn Errors of Metabolism. New York: Raven Press. 9.
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. 10. Rebouche, C.J.
1991. Quantitative estimation of absorption and degradation of a carnitine supplement by human adults. Metabolism 40:1305-1310.
Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213, India Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Rev. 2026-02-27 1400008639 Baxter is a registered trademark of Baxter International Inc.
📋 Description ▾
DESCRIPTION Levocarnitine, USP is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. The chemical name of levocarnitine is ( R )-3-Carboxy-2-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt. Levocarnitine is a white crystalline, hygroscopic powder.
It is freely soluble in water, hot alcohol, and practically insoluble in acetone, ether and benzene. 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 g/mol Levocarnitine injection, USP is a clear, colorless sterile solution containing 1 g of levocarnitine, USP per 5 mL vial and water for injection.
The pH is adjusted to 6.0 to 6.5 with hydrochloric acid or sodium hydroxide. description-1.jpg