Prescription drug · ANDA
Cyclosporine NDC 60505-0134
Cyclosporine 100 mg/1 · Capsule, Gelatin coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0134-0 | 60505013400 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-0)Marketed from May 29, 2002 |
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)
- Cyclosporine
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 100 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065040
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 60505-0134_561ed7a8-f342-f4fe-ce36-998d87c33e7fSPL ID 561ed7a8-f342-f4fe-ce36-998d87c33e7fSPL set ID bfca7088-fe93-abb9-3ec3-e6f5710a69c6RxCUI 197553, 328160UNII 83HN0GTJ6D
- Pharmacologic class
- Calcineurin Inhibitor Immunosuppressant
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
N460505013400followed by a unit qualifier and the quantityPackage 60505-0134-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Cyclosporine capsules, (NON-MODIFIED), in combination with adrenal corticosteroids, are indicated for the: Prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Treatment of chronic rejection in patients previously treated with other immunosuppressive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065040
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 |
|---|---|---|---|---|
| Cyclosporine | Cyclosporine 25 mg/1 | Capsule, Gelatin coatedOral | American Health Packaging | 68084-879 |
| Cyclosporine | Cyclosporine 100 mg/1 | Capsule, Gelatin coatedOral | American Health Packaging | 68084-921 |
| Cyclosporine | Cyclosporine 25 mg/1 | Capsule, Gelatin coatedOral | Apotex Corp. | 60505-0133 |