Afinitor (everolimus) NDC 0078-0620

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-0620Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-0620Add 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
0078-0620-51	00078062051	28 BLISTER PACK in 1 CARTON (0078-0620-51) / 1 TABLET in 1 BLISTER PACK (0078-0620-61)Marketed from Jul 29, 2011

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): Afinitor
Generic name (nonproprietary): everolimus
Active ingredients: Everolimus — 7.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Novartis Pharmaceuticals Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022334
Marketing start: Jul 29, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Decreased Immunologic Activity (Physiologic effect)Protein Kinase Inhibitors (Mechanism)mTOR Inhibitors (Mechanism)
Identifiers: Product ID 0078-0620_b808a4e0-23a8-40c8-834d-b31cd642febeSPL ID b808a4e0-23a8-40c8-834d-b31cd642febeSPL set ID 2150f73a-179b-4afc-b8ce-67c85cc72f04RxCUI 845507, 845512, 845515, 845518, 998189, 998191, 1119400, 1119402, 1308428, 1308430, 1308432, 1310138, 1310144, 1310147UNII 9HW64Q8G6G
Pharmacologic class: Kinase Inhibitor; mTOR 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

N400078062051 followed by a unit qualifier and the quantity

Package 00078-0620-51. 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 Jun 1, 2026.

Indications (excerpt from the label)

AFINITOR is a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1 ) Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced renal cell carcinoma (RCC) after failure of treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022334

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

FDA NDC Directory listings under NDA 022334
Product	Strength	Form · route	Labeler	Product NDC
Afinitoreverolimus	Everolimus 5 mg/1	TabletOral	Novartis Pharmaceuticals Corporation	0078-0566
Afinitoreverolimus	Everolimus 10 mg/1	TabletOral	Novartis Pharmaceuticals Corporation	0078-0567
Afinitoreverolimus	Everolimus 2.5 mg/1	TabletOral	Novartis Pharmaceuticals Corporation	0078-0594