What is NDC 16571-762?

16571-762 is the product NDC for Levocarnitine, Levocarnitine 330 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 16571-762 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-762Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0762Add 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
16571-762-09	1657107620916571076209	9 BLISTER PACK in 1 CARTON (16571-762-09) / 10 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020

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 — 330 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076858
Marketing start: Dec 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Carnitine (Chemical structure)
Identifiers: Product ID 16571-762_ad6d92d4-71c1-481a-a7cf-b2d551c5daadSPL ID ad6d92d4-71c1-481a-a7cf-b2d551c5daadSPL set ID 0f749812-8f02-4eeb-91d9-5dd6fc9fa159RxCUI 197448UNII 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

N416571076209 followed by a unit qualifier and the quantity

Package 16571-0762-09. 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 Aug 19, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Levocarnitine tablets are 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 alleviat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-762

What is NDC 16571-762?: 16571-762 is the product NDC for Levocarnitine, Levocarnitine 330 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. 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?: Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 1 g/10mL	SolutionOral	TRUPHARMA, LLC	52817-830	52817-0830-04
Levocarnitine	Levocarnitine 1 g/10mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-139	70954-0139-10

All 13 Levocarnitine NDCs