Prescription drug · NDA
Cyclophosphamide (Cyclophosphamide injection, solution) NDC 0338-9779
Cyclophosphamide 200 mg/mL · Injection · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-9779-01 | 00338977901 | 1 VIAL in 1 CARTON (0338-9779-01) / 5 mL in 1 VIALMarketed from Aug 1, 2024 |
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)
- Cyclophosphamide
- Generic name (nonproprietary)
- cyclophosphamide injection, solution
- Active ingredients
- Cyclophosphamide — 200 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Baxter Healthcare CompanyNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217651
- Marketing start
- Listing expires
- Identifiers
- Product ID 0338-9779_5c81399c-bacb-48ec-8985-836412a07a6dSPL ID 5c81399c-bacb-48ec-8985-836412a07a6dSPL set ID 34dbffee-80e0-49c3-90e8-95713a0b7fbeRxCUI 2386859UNII 8N3DW7272P
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
N400338977901followed by a unit qualifier and the quantityPackage 00338-9779-01. 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 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 di…
Excerpt only. Read the full label for complete information.
About NDC 0338-9779
- What is NDC 0338-9779?
- 0338-9779 is the product NDC for Cyclophosphamide, Cyclophosphamide 200 mg/mL injection, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyclophosphamide (Cyclophosphamide injection, solution).
- What is the active ingredient?
- Cyclophosphamide.
- Who is the labeler?
- Baxter Healthcare Company, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyclophosphamide?
- 83 other product NDCs are listed under this name. See all Cyclophosphamide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyclophosphamide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cyclophosphamide | Cyclophosphamide 25 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2013 | 70301-2013-01 |
| Cyclophosphamide | Cyclophosphamide 50 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2015 | 70301-2015-01 |
| Cyclophosphamide | Cyclophosphamide 200 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals, LLC | 14789-125 | 14789-0125-05 |
| Cyclophosphamide | Cyclophosphamide 200 mg/mL | InjectionIntravenous | Nexus Pharmaceuticals, LLC | 14789-126 | 14789-0126-05 |
| Cyclophosphamide | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | BluePoint Laboratories | 68001-694 | 68001-0694-27 |
| Cyclophosphamide | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous, Oral | BluePoint Laboratories | 68001-695 | 68001-0695-32 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | BluePoint Laboratories | 68001-696 | 68001-0696-32 |
| Cyclophosphamide | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-205 | 83634-0205-50 |
| Cyclophosphamide | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-206 | 83634-0206-51 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | Avenacy, LLC | 83634-207 | 83634-0207-51 |
Other NDCs under NDA 217651
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 |
|---|---|---|---|---|
| Cyclophosphamidecyclophosphamide injection, solution | Cyclophosphamide 200 mg/mL | InjectionIntravenous | Baxter Healthcare Company | 0338-9777 |