Everolimus NDC 51991-990

NDC codes

FDA NDC Directory

Product NDC (as listed)51991-990Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51991-0990Add 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
51991-990-28	51991099028	4 BLISTER PACK in 1 CARTON (51991-990-28) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (51991-990-99)Marketed from Jan 28, 2025
51991-990-77	51991099077	28 TABLET, FOR SUSPENSION in 1 BOTTLE (51991-990-77)Marketed from Jul 31, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 2 mg/1
Dosage form: Tablet, For suspension
Route: Oral
Labeler: Breckenridge Pharmaceutical, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217640
Marketing start: Jan 28, 2025
Listing expires: Dec 31, 2026
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 51991-990_fade73fb-a367-4c53-83dd-1352c3ad807bSPL ID fade73fb-a367-4c53-83dd-1352c3ad807bSPL set ID 01f7b5fb-be0d-4adf-acd2-6899018de966RxCUI 845507, 845515, 998189, 1119400, 1308428, 1308430, 1308432UNII 9HW64Q8G6GUPC 0351991822332, 0351991823339, 0351991824336, 0351991821335
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

N451991099028 followed by a unit qualifier and the quantity

Package 51991-0990-28. 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 Sep 5, 2025.

Indications (excerpt from the label)

1. INDICATIONS AND USAGE Everolimus tablets are 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: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced re…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217640

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

FDA NDC Directory listings under ANDA 217640
Product	Strength	Form · route	Labeler	Product NDC
Everolimus	Everolimus 5 mg/1	Tablet, For suspensionOral	Breckenridge Pharmaceutical, Inc.	51991-992
Everolimus	Everolimus 3 mg/1	Tablet, For suspensionOral	Breckenridge Pharmaceutical, Inc.	51991-991