Prescription drug · ANDA
Cyclophosphamide NDC 70301-2013
Cyclophosphamide 25 mg/1 · Capsule · Oral · OPKO Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70301-2013-1 | 70301201301 | 100 CAPSULE in 1 BOTTLE (70301-2013-1)Marketed from Sep 16, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- OPKO Pharmaceuticals, LLCNDC labeler code 70301
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218282
- Marketing start
- Listing expires
- Identifiers
- Product ID 70301-2013_5c922933-a668-9f4b-e063-6294a90ae37fSPL ID 5c922933-a668-9f4b-e063-6294a90ae37f
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
N470301201301followed by a unit qualifier and the quantityPackage 70301-2013-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70301-2013
- What is NDC 70301-2013?
- 70301-2013 is the product NDC for Cyclophosphamide, Cyclophosphamide 25 mg/1 capsule, listed with the FDA by OPKO Pharmaceuticals, LLC. 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?
- OPKO Pharmaceuticals, LLC, NDC labeler code 70301. 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 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 |
| Cyclophosphamidecyclophosphamide for injection | Cyclophosphamide 500 mg/25mL | Injection, Powder, For solutionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-105 | 70436-0105-80 |
Other NDCs under ANDA 218282
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 50 mg/1 | CapsuleOral | OPKO Pharmaceuticals, LLC | 70301-2015 |