Prescription drug · ANDA
Cyclophosphamide (Cyclophosphamide for injection) NDC 14335-472
Cyclophosphamide 2 g/100mL · Injection, Powder, For solution · Intravenous · Hainan Poly Pharm. Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14335-472-10 | 1433504721014335047210 | 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-472-10) / 100 mL in 1 VIAL, SINGLE-DOSE (14335-472-01)Marketed from Jan 3, 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)
- Cyclophosphamide
- Generic name (nonproprietary)
- cyclophosphamide for injection
- Active ingredients
- Cyclophosphamide — 2 g/100mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Hainan Poly Pharm. Co., Ltd.NDC labeler code 14335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218632
- Marketing start
- Listing expires
- Identifiers
- Product ID 14335-472_2aca7731-9fcc-4625-e063-6394a90a6020SPL ID 2aca7731-9fcc-4625-e063-6394a90a6020SPL set ID 6fde2705-a2d8-4d48-9618-b9d99d051373RxCUI 1734917, 1734919, 1734921UNII 8N3DW7272PUPC 0314335472013, 0314335470019, 0314335471016
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
N414335047210followed by a unit qualifier and the quantityPackage 14335-0472-10. 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)
Cyclophosphamide for Injection is an alkylating drug indicated for treatment of adults and pediatric patients with: • Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1 ) • Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy ( 1.2 ) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome…
Excerpt only. Read the full label for complete information.
About NDC 14335-472
- What is NDC 14335-472?
- 14335-472 is the product NDC for Cyclophosphamide (cyclophosphamide for injection), Cyclophosphamide 2 g/100mL injection, powder, for solution, listed with the FDA by Hainan Poly Pharm. Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyclophosphamide (Cyclophosphamide for Injection).
- What is the active ingredient?
- Cyclophosphamide.
- Who is the labeler?
- Hainan Poly Pharm. Co., Ltd., NDC labeler code 14335. 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 ANDA 218632
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 for injection | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-470 |
| Cyclophosphamidecyclophosphamide for injection | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-471 |
| Cyclophosphamidecyclophosphamide for injection | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-105 |
| Cyclophosphamidecyclophosphamide for injection | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-106 |
| Cyclophosphamidecyclophosphamide for injection | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-107 |