Levocarnitine (levocarnitine oral) NDC 71656-016

NDC codes

FDA NDC Directory

Product NDC (as listed)71656-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71656-0016Add 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 NDC	11-digit (billing)	Package
71656-016-01	71656001601	100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)Marketed from Feb 21, 2024
71656-016-02	71656001602	100 CUP, UNIT-DOSE in 1 TRAY (71656-016-02) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)Marketed from Feb 21, 2024
71656-016-04	71656001604	118 mL in 1 BOTTLE (71656-016-04)Marketed from Feb 21, 2024
71656-016-50	71656001650	50 CUP, UNIT-DOSE in 1 TRAY (71656-016-50) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05)Marketed from Feb 21, 2024
71656-016-51	71656001651	50 CUP, UNIT-DOSE in 1 TRAY (71656-016-51) / 10 mL in 1 CUP, UNIT-DOSE (71656-016-10)Marketed from Feb 21, 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): Levocarnitine
Generic name (nonproprietary): levocarnitine oral
Active ingredients: Levocarnitine — 1 g/10mL
Dosage form: Solution
Route: Oral
Labeler: Saptalis Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212533
Marketing start: Feb 21, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Carnitine (Chemical structure)
Identifiers: Product ID 71656-016_30a343cc-caab-d417-e063-6394a90ad77bSPL ID 30a343cc-caab-d417-e063-6394a90ad77bSPL set ID 75b43fb1-4486-48a0-b571-7754dce350a3RxCUI 315134UNII 0G389FZZ9MUPC 0371656016043
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

N471656001601 followed by a unit qualifier and the quantity

Package 71656-0016-01. 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 Mar 18, 2025.

Indications (excerpt from the label)

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 all…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212533

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

FDA NDC Directory listings under ANDA 212533
Product	Strength	Form · route	Labeler	Product NDC
Levocarnitine	Levocarnitine 1 g/10mL	SolutionOral	TRUPHARMA, LLC	52817-830