Everolimus NDC 70377-070

NDC codes

FDA NDC Directory

Product NDC (as listed)70377-070Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70377-0070Add 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
70377-070-11	70377007011	60 TABLET in 1 BOTTLE (70377-070-11)Marketed from Jun 2, 2025
70377-070-21	70377007021	6 BLISTER PACK in 1 CARTON (70377-070-21) / 10 TABLET in 1 BLISTER PACKMarketed from Jun 2, 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 — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Biocon Pharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216140
Marketing start: Jun 2, 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 70377-070_7aa24558-b2a2-ed22-b6bc-69a011d2511aSPL ID 7aa24558-b2a2-ed22-b6bc-69a011d2511aSPL set ID 435da284-ef0e-ca90-e0db-bab9382922e0RxCUI 977427, 977434, 977438, 2056895UNII 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

N470377007011 followed by a unit qualifier and the quantity

Package 70377-0070-11. 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 May 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Everolimus 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 216140

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

FDA NDC Directory listings under ANDA 216140
Product	Strength	Form · route	Labeler	Product NDC
Everolimus	Everolimus .25 mg/1	TabletOral	Biocon Pharma Inc.	70377-069
Everolimus	Everolimus .75 mg/1	TabletOral	Biocon Pharma Inc.	70377-071
Everolimus	Everolimus 1 mg/1	TabletOral	Biocon Pharma Inc.	70377-112