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Levocarnitine 1 g/10mL Solution — NDC 71656-0016-51 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Levocarnitine 1 g/10mL Solution — NDC 71656-016-51 (Billing 71656-0016-51)

by Saptalis Pharmaceuticals, LLC · 50 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE

This is a package of Levocarnitine 1 g/10mL Solution from Saptalis Pharmaceuticals, LLC, marketed since Feb 2024 and currently FDA-listed.

NDC 71656-0016-51
🏷️ FDA NDC (as labeled) 71656-016-51 billing pads the product segment with a zero
This package
Contains10 mL in 1 cup, unit-dose Pack sizes5 compare ↓
Also priced by: Part D plans $0.2050/unit — full pricing hub ↓
Product page 71656-0016-01 Also comes in: 50 cups 71656-016-50 100 cups 71656-016-01 100 cups 71656-016-02 118 ml 71656-016-04
Rx only Generic 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 71656-016-51 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71656 labeler · 016 product · 51 package
Package marketed since
Feb 21, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0371656016043
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71656-016-51
Product NDC 71656-016
11-digit billing NDC 71656001651
NCPDP billing unit ML — per mL (volume)
RxCUI 315134
UNII 0G389FZZ9M
UPC 0371656016043
Application # ANDA212533
SPL Set ID 75b43fb1-4486-48a0-b571-7754dce350a3
Established class (EPC) Carnitine Analog
Chemical class Carnitine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-21
Route ORAL
Dosage form SOLUTION
Substance LEVOCARNITINE
TE code (Orange Book) AA · RLD · RS

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

GPI-14 30903045102010
GCN Seq No 062733
GCN 98507
HICL code 034794
Ingredient (HICL) Levocarnitine (With Sugar)
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 LEVOCARNITINE 1 G/10 ML CUP
FDB brand name Levocarnitine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • 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
Why two NDCs? The FDA registers this code as 71656-016-51 — 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 → 71656-0016-51. 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 LEVOCARNITINE 1 G/10 ML CUP Ingredient Levocarnitine (With Sugar)
📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mLPer 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 · Q2 2026 $0.2050 $102.50 / 500 ml
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
71656-0016-01 71656-016-01 Main listing 100 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 2024-02-21 — Active
71656-0016-02 71656-016-02 100 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE 2024-02-21 — Active
71656-0016-04 71656-016-04 118 mL in 1 BOTTLE 2024-02-21 — Active
71656-0016-50 71656-016-50 50 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 2024-02-21 — Active
71656-0016-51 You're viewing this 50 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE 2024-02-21 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 50 cup, unit-dose in 1 tray / 10 ml in 1 cup, unit-dose.
What NDC number is used to bill for this package of Levocarnitine 1 g/10mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levocarnitine 1 g/10mL 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 —
Carnitor 1 g/10mL 54482-0145-08 Leadiant 24 bottles $0.332 AA FDA listed —
Carnitor SF 1 g/10mL 54482-0148-01 Leadiant 24 bottles $0.536 AA FDA listed —
Levocarnitine 1 g/10mLthis 71656-0016-51 Saptalis 50 cups — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2024
On the market since
Feb 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
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.

What it looks like

FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerSaptalis Pharmaceuticals, LLC
Application holderSCIEGEN PHARMACEUTICALS INC
FDA applicationANDA212533 (ANDA)
Labeler code71656
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio7 products on file

More NDCs from Saptalis Pharmaceuticals, LLC labeler code 71656

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 143 words ▾

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 ~1 min read ▾

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 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings 64 words ▾

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 ~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 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 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 74 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 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 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 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 97 words ▾

HOW SUPPLIED Levocarnitine oral solution, USP is a clear colorless to slight yellow solution with cherry flavor, supplied in HDPE bottles with child-resistant caps and as 5 mL and 10 mL unit-dose cups with peelable HDPE lidding, as follows: NDC 71656-016-04 Bottle with a child-resistant cap of 118 mL (4 fl. oz.) NDC 71656-016-50 5 mL fill, Carton of 50s NDC 71656-016-01 5 mL fill, Carton of 100s NDC 71656-016-51 10 mL fill, Carton of 50s NDC 71656-016-02 10 mL fill, Carton of 100s Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF) [see USP].

📋 Description 143 words ▾

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.

Each 5 mL or 10 mL unit-dose cups of levocarnitine oral solution, USP contains 500 mg or 1 g of levocarnitine, USP respectively. 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 ~2 min read ▾

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 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 212 words ▾

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 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 212 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.

Distributed by: Saptalis Pharmaceuticals, LLC Hauppauge, NY 11788 November 2024-R2 PPM-0014

📄 Package Label / Principal Display Panel 200 words ▾

Package/Label Display Panel NDC 71656-016-04 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.)

Package/Label Display Panel 71656-016-10 Levocarnitine Oral Solution, USP 1 g per 10 mL Unit-dose delivers 10 mL Cherry Flavor 10-mL-cup-label

Package/Label Display Panel NDC 71656-016-51 Levocarnitine Oral Solution, USP 1 g per 10 mL Unit-dose delivers 10 mL Cherry Flavor Rx only 5 Trays Contains 50 Unit-dose Cups 10 mL Tray Label

Package/Label Display Panel NDC 71656-016-02 Levocarnitine Oral Solution, USP 1 g per 10 mL Unit-dose delivers 10 mL Cherry Flavor Rx only 10 Trays Contains 100 Unit-dose Cups 10 mL Tray Label

Package/Label Display Panel 71656-016-05 Levocarnitine Oral Solution, USP 500 mg per 5 mL Unit-dose delivers 5 mL Cherry Flavor 5 mL Cup label

Package/Label Display Panel NDC 71656-016-50 Levocarnitine Oral Solution, USP 500 mg per 5 mL Unit-dose delivers 5 mL Cherry Flavor Rx only 5 Trays contain 50 Unit-dose Cups 5 mL Tray Label

Package/Label Display Panel NDC 71656-016-01 Levocarnitine Oral Solution, USP 500 mg per 5 mL Unit-dose delivers 5 mL Cherry Flavor Rx only 10 Trays contain 100 Unit-dose Cups 5 mL Tray Label

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

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

Medicare Part D (outpatient prescription) spending for Levocarnitine — the program that covers self-administered drugs. 3 manufacturers.
⚠️ 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 Levocarnitine. 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
$1.03M
Claims incl. refills
9.6K
Beneficiaries
4.2K
Spend / beneficiary
$246.25
Spend / claim
$106.97
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.

About this NDC listing & data coverage

Finished prescription product
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Saptalis Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 50 cups (71656-0016-50), 100 cups (71656-0016-01), 100 cups (71656-0016-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Saptalis Pharmaceuticals, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71656-0012-30 · Saptalis 71656-0017-04 · Saptalis →
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.