NDC codes

FDA NDC Directory
Product NDC (as listed)70954-139Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70954-0139Add 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
70954-139-107095401391070954013910118 mL in 1 BOTTLE (70954-139-10)Marketed from Aug 14, 2019

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
ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211676
Marketing start
Listing expires
Other FDA classes
Carnitine (Chemical structure)
Identifiers
Product ID 70954-139_83851536-e1cf-4353-af71-abe714a48c9cSPL ID 83851536-e1cf-4353-af71-abe714a48c9cSPL set ID 18dc8eae-56c1-46ec-9d21-e17d7b2f91dbRxCUI 315134UNII 0G389FZZ9MUPC 0370954139102, 0370954140108
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

N470954013910 followed by a unit qualifier and the quantity

Package 70954-0139-10. 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 & USAGE Levocarnitine 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 alleviated signs an…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-139

What is NDC 70954-139?
70954-139 is the product NDC for Levocarnitine, Levocarnitine 1 g/10mL solution, listed with the FDA by ANI Pharmaceuticals, 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?
ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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

Other NDCs under ANDA 211676

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

FDA NDC Directory listings under ANDA 211676
ProductStrengthForm · routeLabelerProduct NDC
LevocarnitineLevocarnitine 1 g/10mLSolutionOralANI Pharmaceuticals, Inc.70954-140

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