Prescription drug · ANDA
Cyclophosphamide (cyclophosphamide for injection) NDC 14335-470
Cyclophosphamide 500 mg/25mL · Injection, Powder, For solution · Intravenous · Hainan Poly Pharm. Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14335-470-10 | 14335047010 | 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-470-10) / 25 mL in 1 VIAL, SINGLE-DOSE (14335-470-01)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 — 500 mg/25mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous
- Labeler
- Hainan Poly Pharm. Co., Ltd.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218632
- Marketing start
- Listing expires
- Identifiers
- Product ID 14335-470_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
N414335047010followed by a unit qualifier and the quantityPackage 14335-0470-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 | 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 |
| Cyclophosphamidecyclophosphamide for injection | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-471 |
| Cyclophosphamidecyclophosphamide for injection | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-472 |