NDC codes

FDA NDC Directory
Product NDC (as listed)54482-147Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54482-0147Add 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
54482-147-0154482014701544820147015 VIAL in 1 CARTON (54482-147-01) / 5 mL in 1 VIALMarketed from Dec 16, 1992

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/5mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Leadiant Biosciences, Inc.NDC labeler code 54482
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020182
Marketing start
Listing expires
Other FDA classes
Carnitine (Chemical structure)
Identifiers
Product ID 54482-147_0a9cb8a2-c17d-9bd3-e063-6294a90ac0e0SPL ID 0a9cb8a2-c17d-9bd3-e063-6294a90ac0e0SPL set ID cf801cc4-775e-433d-9d32-e5d9a98981d3RxCUI 206345, 1791371UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N454482014701 followed by a unit qualifier and the quantity

Package 54482-0147-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54482-147

What is NDC 54482-147?
54482-147 is the product NDC for Carnitor (levocarnitine), Levocarnitine 1 g/5mL injection, solution, listed with the FDA by Leadiant Biosciences, Inc.. It has 1 package NDC, 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.

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

Other Carnitor NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CarnitorlevocarnitineLevocarnitine 1 g/10mLSolutionOralLeadiant Biosciences, Inc.54482-14554482-0145-0854482-0145-09
CarnitorlevocarnitineLevocarnitine 330 mg/1TabletOralLeadiant Biosciences, Inc.54482-14454482-0144-07

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