Prescription drug · NDA
Carnitor SF (levocarnitine) NDC 54482-148
Levocarnitine 1 g/10mL · Solution · Oral · Leadiant Biosciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54482-148-01 | 54482014801 | 24 BOTTLE, PLASTIC in 1 CASE (54482-148-01) / 118 mL in 1 BOTTLE, PLASTICMarketed from Apr 10, 1986 | |
| 54482-148-02 | 54482014802 | 24 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
- Labeler
- Leadiant Biosciences, Inc.
- 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
N454482014801followed by a unit qualifier and the quantityPackage 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.
Other NDCs under NDA 019257
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Carnitorlevocarnitine | Levocarnitine 1 g/10mL | SolutionOral | Leadiant Biosciences, Inc. | 54482-145 |