Prescription drug · ANDA
Cyclophosphamide NDC 46708-618
Cyclophosphamide 25 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-618-31 | 46708061831 | 100 CAPSULE in 1 BOTTLE (46708-618-31)Marketed from Nov 23, 2022 |
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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215892
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-618_9c04aa3c-6a2b-4ad4-b3df-87cc168cf93dSPL ID 9c04aa3c-6a2b-4ad4-b3df-87cc168cf93dSPL set ID 9e699cf7-860e-4c03-9760-0c24d56df2deRxCUI 1437968, 1437969UNII 8N3DW7272PUPC 0346708618315
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N446708061831followed by a unit qualifier and the quantityPackage 46708-0618-31. 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 in pediatric 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 …
Excerpt only. Read the full label for complete information.
About NDC 46708-618
- What is NDC 46708-618?
- 46708-618 is the product NDC for Cyclophosphamide, Cyclophosphamide 25 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 215892
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 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-618 |
| Cyclophosphamide | Cyclophosphamide 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-619 |
| Cyclophosphamide | Cyclophosphamide 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-619 |