Everolimus NDC 72319-017

NDC codes

FDA NDC Directory

Product NDC (as listed)72319-017Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72319-0017Add 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
72319-017-02	72319001702	60 TABLET in 1 CONTAINER (72319-017-02)Marketed from Aug 7, 2026
72319-017-60	72319001760	60 BLISTER PACK in 1 CARTON (72319-017-60) / 10 TABLET in 1 BLISTER PACK (72319-017-10)Marketed from Aug 7, 2026

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 — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: i3 Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219464
Marketing start: Aug 7, 2026
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 72319-017_5afb5d8b-631c-48bd-e063-6294a90acfe3SPL ID 5afb5d8b-631c-48bd-e063-6294a90acfe3SPL set ID be5da0fd-8fd4-4f84-a307-f270048d503cRxCUI 977427, 977434, 977438, 2056895UNII 9HW64Q8G6GUPC 0372319015021, 0372319016103, 0372319017025, 0372319003608, 0372319015106, 0372319003028, 0372319003103, 0372319017605, 0372319015601, 0372319016608, 0372319017100, 0372319016028
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

N472319001702 followed by a unit qualifier and the quantity

Package 72319-0017-02. 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 29, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Everolimus tablest is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney Transplant : at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1) Liver Transplant : Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2 , 5.5 ) Limitations of Use : Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk ( 1.3 ) Recipients of transplanted organs other than kidney or liver ( 1.3 , 5.7 ) Pediatric patients (less than 18 years) ( 1.3 ) 1.1 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219464

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

FDA NDC Directory listings under ANDA 219464
Product	Strength	Form · route	Labeler	Product NDC
Everolimus	Everolimus .25 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-003
Everolimus	Everolimus .5 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-015
Everolimus	Everolimus .75 mg/1	TabletOral	i3 Pharmaceuticals, LLC	72319-016