Prescription drug · NDA
Cyclophosphamide NDC 83831-117
Cyclophosphamide 1 g/2mL · Injection · Intravenous · Avyxa Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83831-117-02 | 83831011702 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-117-02) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 1, 2024 |
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)
- Cyclophosphamide
- Generic name (nonproprietary)
- cyclophosphamide
- Active ingredients
- Cyclophosphamide — 1 g/2mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Avyxa Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210852
- Marketing start
- Listing expires
- Identifiers
- Product ID 83831-117_5fc45658-c2d9-41de-821f-ff6f40a469ddSPL ID 5fc45658-c2d9-41de-821f-ff6f40a469ddSPL set ID 6f593585-e0dd-48bc-bd2b-c6c787e0b98cRxCUI 2644738, 2644751, 2644824UNII 8N3DW7272PUPC 0383831118046, 0383831117025, 0383831116011
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
N483831011702followed by a unit qualifier and the quantityPackage 83831-0117-02. 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 Cyclophosphamide Injection 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) aden…
Excerpt only. Read the full label for complete information.
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 2 g/4mL | InjectionIntravenous | Avyxa Pharma, LLC | 83831-118 |
| Cyclophosphamide | Cyclophosphamide 500 mg/mL | InjectionIntravenous | Avyxa Pharma, LLC | 83831-116 |
| Frindovyxcyclophosphamide | Cyclophosphamide 500 mg/mL | InjectionIntravenous | AVYXA Pharma, LLC | 83831-119 |
| Frindovyxcyclophosphamide | Cyclophosphamide 1 g/2mL | InjectionIntravenous | AVYXA Pharma, LLC | 83831-120 |
| Frindovyxcyclophosphamide | Cyclophosphamide 2 g/4mL | InjectionIntravenous | AVYXA Pharma, LLC | 83831-121 |