Prescription drug · NDA
Neoral (Cyclosporine) NDC 0078-0274
Cyclosporine 100 mg/mL · Solution · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0274-22 | 00078027422 | 1 BOTTLE in 1 CARTON (0078-0274-22) / 50 mL in 1 BOTTLEMarketed from Jul 14, 1995 |
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)
- Neoral
- Generic name (nonproprietary)
- cyclosporine
- Active ingredients
- Cyclosporine — 100 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050716
- Marketing start
- Listing expires
- Other FDA classes
- Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0078-0274_47367e3d-2d79-49bd-849c-5557ef605b27SPL ID 47367e3d-2d79-49bd-849c-5557ef605b27SPL set ID 94461af3-11f1-4670-95d4-2965b9538ae3RxCUI 241834, 835886, 835894, 835899, 835909, 835911UNII 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
N400078027422followed by a unit qualifier and the quantityPackage 00078-0274-22. 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 Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Neoral is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), r…
Excerpt only. Read the full label for complete information.
About NDC 0078-0274
- What is NDC 0078-0274?
- 0078-0274 is the product NDC for Neoral (cyclosporine), Cyclosporine 100 mg/mL solution, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Neoral (Cyclosporine).
- What is the active ingredient?
- Cyclosporine.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Neoral?
- 2 other product NDCs are listed under this name. See all Neoral NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Neoral products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Neoralcyclosporine | Cyclosporine 25 mg/1 | Capsule, Liquid filledOral | Novartis Pharmaceuticals Corporation | 0078-0246 | 00078-0246-15 |
| Neoralcyclosporine | Cyclosporine 100 mg/1 | Capsule, Liquid filledOral | Novartis Pharmaceuticals Corporation | 0078-0248 | 00078-0248-15 |