NDC codes

FDA NDC Directory
Product NDC (as listed)54482-148Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54482-0148Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
54482-148-015448201480124 BOTTLE, PLASTIC in 1 CASE (54482-148-01) / 118 mL in 1 BOTTLE, PLASTICMarketed from Apr 10, 1986
54482-148-025448201480224 BOTTLE, PLASTIC in 1 CASE (54482-148-02) / 118 mL in 1 BOTTLE, PLASTICMarketed from Sep 1, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Carnitor SF
Generic name (nonproprietary)
levocarnitine
Active ingredients
Levocarnitine — 1 g/10mL
Dosage form
Solution
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 019257
Marketing start
Listing expires
Other FDA classes
Carnitine (Chemical structure)
Identifiers
Product ID 54482-148_88041d93-8f95-4551-bba1-df964b092504SPL ID 88041d93-8f95-4551-bba1-df964b092504SPL set ID dd904490-83f3-4cd3-bb6f-68e28509b4b6RxCUI 206343, 315134UNII 0G389FZZ9M
Pharmacologic class
Carnitine Analog

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454482014801 followed by a unit qualifier and the quantity

Package 54482-0148-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

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 alle…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019257

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019257
ProductStrengthForm · routeLabelerProduct NDC
CarnitorlevocarnitineLevocarnitine 1 g/10mLSolutionOralLeadiant Biosciences, Inc.54482-145

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