Prescription drug · NDA
Carnitor (Levocarnitine) NDC 54482-145
Levocarnitine 1 g/10mL · Solution · Oral · Leadiant Biosciences, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54482-145-08 | 5448201450854482014508 | 24 BOTTLE, PLASTIC in 1 CASE (54482-145-08) / 118 mL in 1 BOTTLE, PLASTICMarketed from Apr 10, 1986 | |
| 54482-145-09 | 5448201450954482014509 | 24 BOTTLE, PLASTIC in 1 CASE (54482-145-09) / 118 mL in 1 BOTTLE, PLASTICMarketed from Mar 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
- Generic name (nonproprietary)
- levocarnitine
- Active ingredients
- Levocarnitine — 1 g/10mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Leadiant Biosciences, Inc.NDC labeler code 54482
- 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 54482-145_c1636127-9b6a-4443-81d9-e2607ae46e33SPL ID c1636127-9b6a-4443-81d9-e2607ae46e33SPL set ID b2cbc620-59fd-47b6-9e4b-7e3e31533a1cRxCUI 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
N454482014508followed by a unit qualifier and the quantityPackage 54482-0145-08. 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.
About NDC 54482-145
- What is NDC 54482-145?
- 54482-145 is the product NDC for Carnitor (levocarnitine), Levocarnitine 1 g/10mL solution, listed with the FDA by Leadiant Biosciences, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carnitor (Levocarnitine).
- What is the active ingredient?
- Levocarnitine.
- Who is the labeler?
- Leadiant Biosciences, Inc., NDC labeler code 54482. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carnitor?
- 2 other product NDCs are listed under this name. See all Carnitor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carnitor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carnitorlevocarnitine | Levocarnitine 1 g/5mL | Injection, SolutionIntravenous | Leadiant Biosciences, Inc. | 54482-147 | 54482-0147-01 |
| Carnitorlevocarnitine | Levocarnitine 330 mg/1 | TabletOral | Leadiant Biosciences, Inc. | 54482-144 | 54482-0144-07 |
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 |
|---|---|---|---|---|
| Carnitor SFlevocarnitine | Levocarnitine 1 g/10mL | SolutionOral | Leadiant Biosciences, Inc. | 54482-148 |