Sandimmune (cyclosporine) NDC 0078-0240

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0240Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0240Add 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
0078-0240-15	00078024015	30 BLISTER PACK in 1 PACKAGE (0078-0240-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0240-61)Marketed from Mar 2, 1990

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): Sandimmune
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 050625
Marketing start: Mar 2, 1990
Listing expires: Dec 31, 2027
Other FDA classes: Calcineurin Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0078-0240_e56d1b6b-27a1-48a9-9f4e-de0c5ba08690SPL ID e56d1b6b-27a1-48a9-9f4e-de0c5ba08690SPL set ID 5e5926a7-1de0-4b54-a5c0-286b6200ff82RxCUI 197552, 197553, 205175, 212810, 212844, 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

N400078024015 followed by a unit qualifier and the quantity

Package 00078-0240-15. 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 Jul 10, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Sandimmune capsules and Sandimmune injection, 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. Because of the risk of anaphylaxis, Sandimmune injection should be reserved for patients who are unable to take the Sandimmune capsules.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050625

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

FDA NDC Directory listings under NDA 050625
Product	Strength	Form · route	Labeler	Product NDC
Sandimmunecyclosporine	Cyclosporine 100 mg/1	Capsule, Liquid filledOral	Novartis Pharmaceuticals Corporation	0078-0241