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Carnitor levocarnitine 330 mg Tablet, 90-count — NDC 54482-0144-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Carnitor levocarnitine 330 mg Tablet, 90-count — NDC 54482-144-07 (Billing 54482-0144-07)

by Leadiant Biosciences, Inc. · 10 BLISTER PACK in 1 CARTON / 9 TABLET in 1 BLISTER PACK

This is a package of 90 tablets of Carnitor levocarnitine 330 mg Tablet from Leadiant Biosciences, Inc., marketed since Dec 1985 and currently FDA-listed; retail pharmacies pay about $1.23 per tablet (NADAC). It is this product's only package size.

NDC 54482-0144-07
🏷️ FDA NDC (as labeled) 54482-144-07 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 54482-144-07 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
54482 labeler · 144 product · 07 package
Package marketed since
Dec 27, 1985
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
90 EA per package
Barcode (UPC-A, from the NDC)
3 5448214407 4
Medicaid fills, this package
339 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Levocarnitine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Apr 16, 2026 — Labeling: Missing Label (American Regent, Inc.) · FDA recall D-0494-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54482-144-07
Product NDC 54482-144
11-digit billing NDC 54482014407
NCPDP billing unit EA — each (per item)
RxCUI 197448, 206346
UNII 0G389FZZ9M
Application # NDA018948
SPL Set ID d2133bc3-9c15-48bd-8b16-b8995a6a14cd
Established class (EPC) Carnitine Analog
Chemical class Carnitine
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1985-12-27
Route ORAL
Dosage form TABLET
Substance LEVOCARNITINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 30903045100330
GPI class Carnitor
GCN Seq No 040520
GCN 85384
HICL code 000859
Ingredient (HICL) Levocarnitine
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C7
Therapeutic class — intermediate (HIC2) Metabolic Inhibitors And Stimulants
HIC3 code C7D
Therapeutic class — specific (HIC3) Metabolic Deficiency Agents
AHFS code 92:92.00.00
AHFS class Other Miscellaneous Therapeutic Agents
FDB label name CARNITOR 330 MG TABLET
FDB brand name Carnitor
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 040520
  • GCN: 85384
  • GPI-14 (Medi-Span): 30903045100330
  • HICL (First Databank): 000859
  • AHFS class code: 92:92.00.00
  • RxCUI (RxNorm): 197448
Why two NDCs? The FDA registers this code as 54482-144-07 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 54482-0144-07. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Carnitine Analog class.

Pharmacologic class Carnitine Analog
Drug family (ATC) Amino acids and derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CARNITOR 330 MG TABLET Ingredient Levocarnitine
📗 Our plain-language guide HelloPharmacist
  • 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,...
📖 Read our full Levocarnitine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.227 $110.45 / 90 tablets
Medicaid paysCMS SDUD · 12 mo $1.13 $101.63 / 90 tablets
Medicare drug plans payPart D · Q2 2026 $1.26 $113.63 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2024 Nov 2025 $1.227 $0.895
▲ Up 37% over the last 4 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
54482-0144-07 You're viewing this Main listing 10 BLISTER PACK in 1 CARTON / 9 TABLET in 1 BLISTER PACK 1985-12-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levocarnitine 330 mg 16571-0762-09 Rising 90 tablets $0.671 AB Availability likely save 45%
Levocarnitine 330 mg 70954-0492-10 ANI 900 tablets $0.671 AB Availability likely save 45%
Carnitor 330 mgthis 54482-0144-07 Leadiant 90 tablets $1.227 AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1985
On the market since
Dec 1985
📍
2026
Currently FDA-listed
41 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Levocarnitine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLeadiant Biosciences, Inc.
Application holderLEADIANT BIOSCIENCES INC
FDA applicationNDA018948 (NDA)
Labeler code54482
First marketedDec 1985
Product typeHuman Prescription Drug
Portfolio7 products on file

More NDCs from Leadiant Biosciences, Inc. labeler code 54482

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 142 words ▾

INDICATIONS AND USAGE CARNITOR ® (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.

CARNITOR ® (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 ~2 min read ▾

DOSAGE AND ADMINISTRATION CARNITOR ® (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.

CARNITOR ® (levocarnitine) Oral Solution and CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution. 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 CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free 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 CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free 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. CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free 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 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 68 words ▾

WARNINGS Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral CARNITOR ® . 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 CARNITOR ® and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction.

🤒 Adverse Reactions ~1 min read ▾

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 CARNITOR ® (levocarnitine) Oral Solution or CARNITOR ® SF (levocarnitine) Sugar-Free 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 CARNITOR ® (see WARNINGS ).

🔄 Drug Interactions 38 words ▾

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 77 words ▾

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 CARNITOR ® . 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 7 words ▾

Pediatric Use See DOSAGE AND ADMINISTRATION .

🆘 Overdosage 49 words ▾

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 ~1 min read ▾

CLINICAL PHARMACOLOGY CARNITOR ® (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 CARNITOR ® .

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. CARNITOR ® 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 163 words ▾

HOW SUPPLIED CARNITOR ® (levocarnitine) Tablets are supplied as 330 mg tablets embossed with "CARNITOR ST" in individual blisters, packaged in boxes of 90 (NDC 54482-144-07). Store in original packaging: content hygroscopic. Store at 20°C to 25°C (68°F to 77°F).

See USP Controlled Room Temperature. CARNITOR ® (levocarnitine) Tablets are distributed by Leadiant Biosciences, Inc. CARNITOR ® (levocarnitine) Oral Solution is supplied in 118 mL (4 FL.

OZ.) plastic containers (NDC 54482-145-08 and NDC 54482-145-09). Store at 20°C to 25°C (68°F to 77°F). See USP Controlled Room Temperature.

Avoid excessive heat and protect from freezing. CARNITOR ® (levocarnitine) Oral Solution is distributed by Leadiant Biosciences, Inc. CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution is supplied in 118 mL (4 FL.

OZ.) plastic containers (NDC 54482-148-01 and NDC 54482-148-02). Store at 20°C to 25°C (68°F to 77°F). See USP Controlled Room Temperature.

Avoid excessive heat and protect from freezing. CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution is distributed by Leadiant Biosciences, Inc. Rx only.

📋 Description 181 words ▾

DESCRIPTION CARNITOR ® (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 CARNITOR ® (levocarnitine) Tablet contains 330 mg of levocarnitine and the inactive ingredients magnesium stearate, microcrystalline cellulose and povidone.

Each 118 mL container of CARNITOR ® (levocarnitine) Oral Solution contains 1 g of levocarnitine/10 mL. Also contains: Artificial Cherry Flavor, D,L,-Malic Acid, Purified Water, Sucrose. Methylparaben NF and Propylparaben NF are added as preservatives.

The pH is approximately 5. Each 118 mL container of CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution contains 1 g of levocarnitine/10 mL. Also contains: Natural 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. Chemical Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General CARNITOR ® (levocarnitine) Oral Solution and CARNITOR ® SF (levocarnitine) Sugar-Free Oral Solution are for oral/internal use only. Not for parenteral use. Gastrointestinal reactions may result from a too rapid consumption of carnitine.

CARNITOR ® (levocarnitine) Oral Solution and CARNITOR ® SF (levocarnitine) Sugar-Free 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 has 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 CARNITOR ® .

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 70 words ▾

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 ~1 min read ▾

PHARMACOKINETICS In a relative bioavailability study in 15 healthy adult male volunteers, CARNITOR ® Tablets were found to be bio-equivalent to CARNITOR ® Oral Solution. Following 4 days of dosing with 6 tablets of CARNITOR ® 330 mg b.i.d. or 2 g of CARNITOR ® 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 CARNITOR ® 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 CARNITOR ® , calculated after correction for circulating endogenous plasma concentrations of levocarnitine, was 15.1 ± 5.3% for CARNITOR ® Tablets and 15.9 ± 4.9% for CARNITOR ® 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 36 words ▾

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 207 words ▾

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. PREVIOUS EDITION IS OBSOLETE Date of Issue: 07/23 OPI-16 Leadiant Logo

📄 Package Label / Principal Display Panel 59 words ▾

PRINCIPAL DISPLAY PANEL - 330 mg Tablet Blister Pack Carton CARNITOR ® (levocarnitine) 330 mg tablets 90 Tablets Dosage: See package insert. Store at controlled room temperature (25°C). See USP. Rx only. MADE IN ITALY NDC 54482-144-07 TC(I)-5 0519 Leadiant Biosciences Distributed by: Leadiant Biosciences, Inc. Gaithersburg, MD 20878 PRINCIPAL DISPLAY PANEL - 330 mg Tablet Blister Pack Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
339
Units reimbursed last 4 qtrs
38.5K
Gross reimbursed last 4 qtrs
$43.5K
Avg / prescription
$128.19
Avg / unit
$1.1292
Latest quarter Q1 2026
72Rx
Medicaid pays / ea
$1.1292
gross reimbursed
vs
NADAC / ea
$1.2272
acquisition cost
=
Spread
−$0.0980
-8% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
74% FFS 26% MCO
Fee-for-service · 252 Rx Managed care · 87 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 13,530 units · 69.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 11,304 units · 29.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 2,514 units · 40.6 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 1,926 units · 17.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 9,211 units · 30.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
17.869.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 69.1 /100k
2 Missouri 40.6 /100k
3 Texas 30.2 /100k
4 California 29.0 /100k
5 North Carolina 17.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Carnitor — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Carnitor. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$63.8K
Claims incl. refills
232
Beneficiaries
91
Spend / beneficiary
$700.59
Spend / claim
$274.80
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 54482-0054-01 · Leadiant 54482-0145-08 · Leadiant →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.