Prescription drug · ANDA
Cyclosporine NDC 0172-7313
Cyclosporine 100 mg/mL · Solution · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0172-7313-20 | 00172731320 | 1 BOTTLE in 1 PACKAGE (0172-7313-20) / 50 mL in 1 BOTTLEMarketed from Mar 29, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Cyclosporine
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 100 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065078
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0172-7313_94a2cdae-e60e-47c4-8bca-8baac9f21b33SPL ID 94a2cdae-e60e-47c4-8bca-8baac9f21b33SPL set ID f3dc2a50-1084-4190-a6f3-37034a04db86RxCUI 835886UNII 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
N400172731320followed by a unit qualifier and the quantityPackage 00172-7313-20. 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 Kidney, Liver, and Heart Transplantation Cyclosporine oral solution, USP MODIFIED is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine oral solution, USP MODIFIED has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine oral solution, USP MODIFIED is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine oral solution, USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. P…
Excerpt only. Read the full label for complete information.