Everolimus NDC 0054-0482

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0482Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0482Add 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
0054-0482-13	00054048213	30 TABLET in 1 BOTTLE (0054-0482-13)Marketed from Dec 7, 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): Everolimus
Generic name (nonproprietary): everolimus
Active ingredients: Everolimus — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207486
Marketing start: Jun 8, 2020
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 0054-0482_03212bec-ec7b-4045-ac2b-0cc073e92d32SPL ID 03212bec-ec7b-4045-ac2b-0cc073e92d32SPL set ID 5aaf2fb7-93f6-40d6-941a-9583a3794ce7RxCUI 845507, 845515, 998189, 1119400UNII 9HW64Q8G6GUPC 0300540481131, 0300540482138, 0300540480134
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

N400054048213 followed by a unit qualifier and the quantity

Package 00054-0482-13. 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 14, 2026.

Indications (excerpt from the label)

Everolimus is a kinase inhibitor indicated for the treatment of: • Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. ( 1.3 ) • Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) 1.3 Renal Cell Carcinoma (RCC) Everolimus is indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib. 1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma Everolimus is indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207486

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

FDA NDC Directory listings under ANDA 207486
Product	Strength	Form · route	Labeler	Product NDC
Everolimus	Everolimus 2.5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0480
Everolimus	Everolimus 7.5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0497
Everolimus	Everolimus 5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0481