What is NDC 52817-830?

52817-830 is the product NDC for Levocarnitine, Levocarnitine 1 g/10mL solution, listed with the FDA by TRUPHARMA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

TRUPHARMA, LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Levocarnitine?

12 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Levocarnitine NDC 52817-830 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)52817-830Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52817-0830Add 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	Copy
52817-830-04	5281708300452817083004	118 mL in 1 BOTTLE (52817-830-04)Marketed from Feb 9, 2022

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
Active ingredients: Levocarnitine — 1 g/10mL
Dosage form: Solution
Route: Oral
Labeler: TRUPHARMA, LLCNDC labeler code 52817
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212533
Marketing start: Feb 9, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Carnitine (Chemical structure)
Identifiers: Product ID 52817-830_2a4543d7-2fcf-548c-e063-6394a90af66eSPL ID 2a4543d7-2fcf-548c-e063-6394a90af66eSPL set ID 05ab18c1-fb01-48fa-8f05-0200bb8a5edfRxCUI 315134UNII 0G389FZZ9MUPC 0352817830043
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

N452817083004 followed by a unit qualifier and the quantity

Package 52817-0830-04. 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 Dec 27, 2024.

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)

About NDC 52817-830

What is NDC 52817-830?: 52817-830 is the product NDC for Levocarnitine, Levocarnitine 1 g/10mL solution, listed with the FDA by TRUPHARMA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Levocarnitine.
What is the active ingredient?: Levocarnitine.
Who is the labeler?: TRUPHARMA, LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levocarnitine?: 12 other product NDCs are listed under this name. See all Levocarnitine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Levocarnitine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
levocarnitine	Levocarnitine 1 g/5mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-681	68083-0681-05
Levocarnitine	Levocarnitine 1 g/5mL	Injection, SolutionIntravenous	Baxter Healthcare Corporation	36000-368	36000-0368-10
levocarnitine	Levocarnitine 1 g/5mL	Injection, SolutionIntravenous	Devatis Inc.	73043-034	73043-0034-05
Levocarnitinelevocarnitine oral	Levocarnitine 1 g/10mL	SolutionOral	Saptalis Pharmaceuticals, LLC	71656-016	71656-0016-0171656-0016-0271656-0016-04+2 more
Levocarnitine	Levocarnitine 200 mg/mL	Injection, SolutionIntravenous	American Regent, Inc.	0517-1045	00517-1045-05
Levocarnitine	Levocarnitine 200 mg/mL	Injection, SolutionIntravenous	American Regent, Inc.	0517-1075	00517-1075-01
Levocarnitine	Levocarnitine 1 g/5mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9852	00143-9852-10
Levocarnitine	Levocarnitine 330 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-492	70954-0492-10
Levocarnitine	Levocarnitine 330 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-762	16571-0762-09
Levocarnitine	Levocarnitine 1 g/10mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-139	70954-0139-10

All 13 Levocarnitine NDCs

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
Levocarnitinelevocarnitine oral	Levocarnitine 1 g/10mL	SolutionOral	Saptalis Pharmaceuticals, LLC	71656-016