Prescription drug · ANDA
Cyclosporine Modified (cyclosporine) NDC 0093-9018
Cyclosporine 25 mg/1 · Capsule, Liquid filled · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-9018-65 | 00093901865 | 30 BLISTER PACK in 1 CARTON (0093-9018-65) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9018-19)Marketed from Jun 8, 2021 |
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 ModifiedSuffix: Modified
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065110
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-9018_d5d977b4-fc80-4e46-ab55-280fd6d4ea12SPL ID d5d977b4-fc80-4e46-ab55-280fd6d4ea12SPL set ID 2de1e8b1-625f-43ce-a1d5-d543be208b11RxCUI 241834, 835894, 835925UNII 83HN0GTJ6DUPC 0300939018658
- 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
N400093901865followed by a unit qualifier and the quantityPackage 00093-9018-65. 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 capsules, USP MODIFIED are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP MODIFIED have been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules, USP MODIFIED are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules, USP MODIFIED can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Cyclospo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065110
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 Modifiedcyclosporine | Cyclosporine 50 mg/1 | Capsule, Liquid filledOral | Teva Pharmaceuticals USA, Inc. | 0093-9019 |
| Cyclosporine Modifiedcyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Teva Pharmaceuticals USA, Inc. | 0093-9020 |