NDC codes

FDA NDC Directory
Product NDC (as listed)64980-503Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0503Add 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 NDC11-digit (billing)PackageCopy
64980-503-126498005031264980050312118 mL in 1 BOTTLE, PLASTIC (64980-503-12)Marketed from Sep 20, 2004

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
Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076851
Marketing start
Listing expires
Other FDA classes
Carnitine (Chemical structure)
Identifiers
Product ID 64980-503_3beded34-64c8-4a1d-80d4-02b3007233b9SPL ID 3beded34-64c8-4a1d-80d4-02b3007233b9SPL set ID ada35959-e317-4161-ae79-3475096c679fRxCUI 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

N464980050312 followed by a unit qualifier and the quantity

Package 64980-0503-12. 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 Levocarnitine Oral Solution USP 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-503

What is NDC 64980-503?
64980-503 is the product NDC for Levocarnitine, Levocarnitine 1 g/10mL solution, 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 64980. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
levocarnitineLevocarnitine 1 g/5mLInjection, SolutionIntravenousGland Pharma Limited68083-68168083-0681-05
LevocarnitineLevocarnitine 1 g/5mLInjection, SolutionIntravenousBaxter Healthcare Corporation36000-36836000-0368-10
levocarnitineLevocarnitine 1 g/5mLInjection, SolutionIntravenousDevatis Inc.73043-03473043-0034-05
Levocarnitinelevocarnitine oralLevocarnitine 1 g/10mLSolutionOralSaptalis Pharmaceuticals, LLC71656-01671656-0016-0171656-0016-0271656-0016-04+2 more
LevocarnitineLevocarnitine 200 mg/mLInjection, SolutionIntravenousAmerican Regent, Inc.0517-104500517-1045-05
LevocarnitineLevocarnitine 200 mg/mLInjection, SolutionIntravenousAmerican Regent, Inc.0517-107500517-1075-01
LevocarnitineLevocarnitine 1 g/5mLInjectionIntravenousHikma Pharmaceuticals USA Inc.0143-985200143-9852-10
LevocarnitineLevocarnitine 330 mg/1TabletOralANI Pharmaceuticals, Inc.70954-49270954-0492-10
LevocarnitineLevocarnitine 1 g/10mLSolutionOralTRUPHARMA, LLC52817-83052817-0830-04
LevocarnitineLevocarnitine 330 mg/1TabletOralRising Pharma Holdings, Inc.16571-76216571-0762-09

All 13 Levocarnitine NDCs

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