Neoral (cyclosporine) NDC 0078-0246

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0246Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0246Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0078-0246-15	00078024615	30 BLISTER PACK in 1 CARTON (0078-0246-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0246-61)Marketed 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 — 25 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Novartis Pharmaceuticals Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050715
Marketing start: Jul 14, 1995
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0078-0246_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

N400078024615 followed by a unit qualifier and the quantity

Package 00078-0246-15. 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 Aug 10, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050715

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 050715
Product	Strength	Form · route	Labeler	Product NDC
Neoralcyclosporine	Cyclosporine 100 mg/1	Capsule, Liquid filledOral	Novartis Pharmaceuticals Corporation	0078-0248