Prescription drug · NDA
Cyclophosphamide NDC 75907-189
Cyclophosphamide anhydrous 200 mg/mL · Injection, Solution · Intravenous · Dr. Reddy's Labratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-189-35 | 75907018935 | 1 VIAL in 1 CARTON (75907-189-35) / 10 mL in 1 VIALMarketed from Jun 20, 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 anhydrous — 200 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Dr. Reddy's Labratories Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212501
- Marketing start
- Listing expires
- Identifiers
- Product ID 75907-189_81f6f0e0-48f4-4eb1-95e5-b1463e5f53f5SPL ID 81f6f0e0-48f4-4eb1-95e5-b1463e5f53f5SPL set ID a5818647-d840-e9d7-c7b8-6541b485e44eRxCUI 2386859UNII 6UXW23996MUPC 0375907191022
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
N475907018935followed by a unit qualifier and the quantityPackage 75907-0189-35. 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 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 ) 1.1 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 lympho…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 212501
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 anhydrous 200 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-564 |
| Cyclophosphamide | Cyclophosphamide anhydrous 200 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-565 |
| Cyclophosphamide | Cyclophosphamide anhydrous 200 mg/mL | Injection, SolutionIntravenous | Dr. Reddy's Labratories Inc. | 75907-191 |
| Cyclophosphamide | Cyclophosphamide anhydrous 200 mg/mL | Injection, SolutionIntravenous | Dr. Reddy's Labratories Inc. | 75907-190 |