NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9558Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9558Add 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
0143-9558-0100143955801001439558011 VIAL in 1 BOX (0143-9558-01) / 5 mL in 1 VIALMarketed from Jul 7, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Levoleucovorin
Generic name (nonproprietary)
levoleucovorin
Active ingredients
Levoleucovorin calcium — 50 mg/5mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206263
Marketing start
Listing expires
Other FDA classes
Folic Acid (Chemical structure)
Identifiers
Product ID 0143-9558_d5427bbc-8598-4e79-9aeb-b0a9317e3433SPL ID d5427bbc-8598-4e79-9aeb-b0a9317e3433SPL set ID 54f01988-aac2-4b0e-9d20-b7f621a0cd50RxCUI 1720760UNII 778XL6VBS8
Pharmacologic class
Folate 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

N400143955801 followed by a unit qualifier and the quantity

Package 00143-9558-01. 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)

Levoleucovorin for Injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use Levoleucovorin for Injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B12, because of the risk of progression of neurologic manifestations despite hematologic remission. Levoleucovorin for Injection is a folate analog indicated for: Rescue aft…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9558

What is NDC 0143-9558?
0143-9558 is the product NDC for Levoleucovorin, Levoleucovorin calcium 50 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Levoleucovorin.
What is the active ingredient?
Levoleucovorin calcium.
Who is the labeler?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Levoleucovorin?
6 other product NDCs are listed under this name. See all Levoleucovorin 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 Levoleucovorin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Levoleucovorinlevoleucovorin calciumLevoleucovorin calcium 50 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousMeitheal Pharmaceuticals Inc71288-104—
Levoleucovorinlevoleucovorin calciumLevoleucovorin calcium 10 mg/mLInjection, SolutionIntravenousMeitheal Pharmaceuticals Inc.71288-10571288-0105-1871288-0105-25
LevoleucovorinLevoleucovorin calcium 175 mg/17.5mLInjection, SolutionIntravenousDr.Reddy's Laboratories Inc43598-77143598-0771-11
LevoleucovorinLevoleucovorin calcium 250 mg/25mLInjection, SolutionIntravenousDr.Reddy's Laboratories Inc43598-77343598-0773-11
levoleucovorinLevoleucovorin calcium 10 mg/mLInjectionIntravenousGland Pharma Limited68083-27868083-0278-01
levoleucovorinLevoleucovorin calcium 10 mg/mLInjectionIntravenousGland Pharma Limited68083-27968083-0279-01

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