Vykoura Injection
NDC Package 83831-147-05
Package Information
Vykoura (leucovorin calcium) injection is a medication used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). This formulation utilizes a injection delivery system. Marketed by Avyxa Pharma, Llc, this product is identified by NDC 83831-147 and is authorized under FDA application NDA220406.
Identification & Billing
- RxCUI: 2104714 - leucovorin 500 MG in 50 ML Injection
- RxCUI: 2104714 - 50 ML leucovorin 10 MG/ML Injection
- RxCUI: 2104714 - leucovorin (as leucovorin calcium) 500 MG per 50 ML Injection
- RxCUI: 2104714 - leucovorin 500 MG per 50 ML Injection
- RxCUI: 2735355 - leucovorin 350 MG in 35 ML Injection
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Intravenous - Administration within or into a vein or veins.
Regulatory & Marketing
Hierarchy Structure
- 83831 - Avyxa Pharma, Llc
- 83831-147 - Vykoura
- 83831-147-05 - 1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE
- 83831-147 - Vykoura
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 83831-147-05 identifies a specific commercial package of 1 vial, single-use in 1 carton / 5 ml in 1 vial, single-use of Vykoura, a human prescription drug labeled by Avyxa Pharma, Llc. This injection is formulated for intramuscular; intravenous use and contains leucovorin calcium as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avyxa Pharma, Llc on March 16, 2026. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine). It may also be used with a certain cancer drug (5-fluorouracil) to treat patients with colon cancer. Leucovorin may also be used to treat a certain type of anemia (due to folic acid deficiency) when folic acid cannot be taken by mouth.
How is this Avyxa Pharma, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 83831014705. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
