Prescription drug · ANDA
Levoleucovorin NDC 0143-9558
Levoleucovorin calcium 50 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9558-01 | 00143955801 | 1 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
- 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.
- NDC on a medical claim
N400143955801followed by a unit qualifier and the quantityPackage 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.