Prescription drug · ANDA
Cyclophosphamide NDC 83703-550
Cyclophosphamide 1 g/50mL · Injection, Powder, For solution · Intravenous, Oral · Bamboo US Bidco LCC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83703-550-01 | 8370305500183703055001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83703-550-01) / 50 mL in 1 VIAL, SINGLE-DOSE (83703-550-50)Marketed from May 21, 2008 |
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/50mL
- Dosage form
- Injection, Powder, For solution
- Route
- Intravenous, Oral
- Labeler
- Bamboo US Bidco LCCNDC labeler code 83703
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040745
- Marketing start
- Listing expires
- Identifiers
- Product ID 83703-550_450da59c-b50e-4de0-e063-6394a90a0559SPL ID 450da59c-b50e-4de0-e063-6394a90a0559SPL set ID 2873b99a-830d-0a7b-e063-6394a90a4de7RxCUI 1734917, 1734919, 1734921UNII 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
N483703055001followed by a unit qualifier and the quantityPackage 83703-0550-01. 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)
Cyclophosphamide is an alkylating drug indicated for treatment of: 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 in adults or other renal disease has not been esta…
Excerpt only. Read the full label for complete information.
About NDC 83703-550
- What is NDC 83703-550?
- 83703-550 is the product NDC for Cyclophosphamide, Cyclophosphamide 1 g/50mL injection, powder, for solution, listed with the FDA by Bamboo US Bidco LCC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyclophosphamide.
- What is the active ingredient?
- Cyclophosphamide.
- Who is the labeler?
- Bamboo US Bidco LCC, NDC labeler code 83703. 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 040745
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 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-935 |
| Cyclophosphamide | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-936 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-937 |
| Cyclophosphamide | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-938 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-942 |
| Cyclophosphamide | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-943 |
| Cyclophosphamide | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-944 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-945 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | Civica, Inc. | 72572-083 |
| Cyclophosphamide | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous, Oral | Civica, Inc. | 72572-085 |
| Cyclophosphamide | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | Civica, Inc. | 72572-087 |
| Cyclophosphamide | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-955 |
| Cyclophosphamide | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | BluePoint Laboratories | 68001-442 |
| Cyclophosphamide | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous, Oral | BluePoint Laboratories | 68001-443 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | BluePoint Laboratories | 68001-444 |
| Cyclophosphamide | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-956 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-957 |
| Cyclophosphamide | Cyclophosphamide 1 g/50mL | Injection, Powder, For solutionIntravenous, Oral | Baxter Healthcare Company | 10019-939 |
| Cyclophosphamide | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous, Oral | Bamboo US Bidco LCC | 83703-549 |
| Cyclophosphamide | Cyclophosphamide 2 g/100mL | Injection, Powder, For solutionIntravenous, Oral | Bamboo US Bidco LCC | 83703-551 |