Prescription drug · NDA
Frindovyx (Cyclophosphamide) NDC 83831-119
Cyclophosphamide 500 mg/mL · Injection · Intravenous · AVYXA Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83831-119-01 | 8383101190183831011901 | 1 VIAL, MULTI-DOSE in 1 CARTON (83831-119-01) / 1 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 19, 2025 |
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)
- Frindovyx
- Generic name (nonproprietary)
- cyclophosphamide
- Active ingredients
- Cyclophosphamide — 500 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- AVYXA Pharma, LLCNDC labeler code 83831
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210852
- Marketing start
- Listing expires
- Identifiers
- Product ID 83831-119_e3e444b2-9344-4cc2-b35a-370073a747d4SPL ID e3e444b2-9344-4cc2-b35a-370073a747d4SPL set ID 5ad8ea65-4c98-487a-9c8d-df778765ec5eRxCUI 2703027, 2703032UNII 8N3DW7272PUPC 0383831121046, 0383831120025, 0383831119012
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
N483831011901followed by a unit qualifier and the quantityPackage 83831-0119-01. 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)
Malignant Diseases FRINDOVYX is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma multiple myeloma leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) mycosis fungoides (advanced disease) neuroblastoma (disseminated disease) adenocarcinoma of the…
Excerpt only. Read the full label for complete information.
About NDC 83831-119
- What is NDC 83831-119?
- 83831-119 is the product NDC for Frindovyx (cyclophosphamide), Cyclophosphamide 500 mg/mL injection, listed with the FDA by AVYXA Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Frindovyx (Cyclophosphamide).
- What is the active ingredient?
- Cyclophosphamide.
- Who is the labeler?
- AVYXA Pharma, LLC, NDC labeler code 83831. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Frindovyx?
- 2 other product NDCs are listed under this name. See all Frindovyx NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Frindovyx products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Frindovyxcyclophosphamide | Cyclophosphamide 1 g/2mL | InjectionIntravenous | AVYXA Pharma, LLC | 83831-120 | 83831-0120-02 |
| Frindovyxcyclophosphamide | Cyclophosphamide 2 g/4mL | InjectionIntravenous | AVYXA Pharma, LLC | 83831-121 | 83831-0121-04 |
Other NDCs under NDA 210852
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 |
|---|---|---|---|---|
| Cyclophosphamide | Cyclophosphamide 500 mg/mL | InjectionIntravenous | Avyxa Pharma, LLC | 83831-116 |
| Cyclophosphamide | Cyclophosphamide 1 g/2mL | InjectionIntravenous | Avyxa Pharma, LLC | 83831-117 |
| Cyclophosphamide | Cyclophosphamide 2 g/4mL | InjectionIntravenous | Avyxa Pharma, LLC | 83831-118 |
| Frindovyxcyclophosphamide | Cyclophosphamide 1 g/2mL | InjectionIntravenous | AVYXA Pharma, LLC | 83831-120 |
| Frindovyxcyclophosphamide | Cyclophosphamide 2 g/4mL | InjectionIntravenous | AVYXA Pharma, LLC | 83831-121 |