Prescription drug · NDA
Vykoura (leucovorin calcium) NDC 83831-147
Leucovorin calcium 50 mg/5mL · Injection · Intramuscular, Intravenous · Avyxa Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83831-147-05 | 83831014705 | 1 VIAL, SINGLE-USE in 1 CARTON (83831-147-05) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Mar 16, 2026 |
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)
- Vykoura
- Generic name (nonproprietary)
- leucovorin calcium
- Active ingredients
- Leucovorin calcium — 50 mg/5mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Avyxa Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 220406
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 83831-147_c655613e-4381-461e-8e2d-4121be761c04SPL ID c655613e-4381-461e-8e2d-4121be761c04SPL set ID d122b875-435e-4e00-b945-7a0546df95c2RxCUI 2104714, 2735355, 2735359, 2735364, 2735365, 2735366UNII RPR1R4C0P4UPC 0383831147053, 0383831148357, 0383831149507
- 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
N483831014705followed by a unit qualifier and the quantityPackage 83831-0147-05. 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)
VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 Reducing the toxicity of: Methotrexate in adult and pediatric patients with impaired methotrexate elimination or Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients. 1.3 Treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible. 1.4 Treatment of patients with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use VYKOURA is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vi…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 220406
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Vykouraleucovorin calcium | Leucovorin calcium 350 mg/35mL | InjectionIntramuscular, Intravenous | Avyxa Pharma, LLC | 83831-148 |
| Vykouraleucovorin calcium | Leucovorin calcium 500 mg/50mL | InjectionIntramuscular, Intravenous | Avyxa Pharma, LLC | 83831-149 |