NDC codes

FDA NDC Directory
Product NDC (as listed)67877-718Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0718Add 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 NDC11-digit (billing)PackageCopy
67877-718-31678770718316 BLISTER PACK in 1 CARTON (67877-718-31) / 10 TABLET in 1 BLISTER PACK (67877-718-33)Marketed from Nov 27, 2021
67877-718-606787707186060 TABLET in 1 BOTTLE (67877-718-60)Marketed from Mar 1, 2024

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.25 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214138
Marketing start
Listing expires
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 67877-718_33247fe5-9b47-4513-93fe-fc65e4c1b63fSPL ID 33247fe5-9b47-4513-93fe-fc65e4c1b63fSPL set ID 2693c497-a70b-4d00-b6db-602c872e5bedRxCUI 977427, 977434, 977438, 2056895UNII 9HW64Q8G6GUPC 0367877721316, 0367877720319, 0367877719313, 0367877718316
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

N467877071831 followed by a unit qualifier and the quantity

Package 67877-0718-31. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Everolimus tablets are a 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214138

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

FDA NDC Directory listings under ANDA 214138
ProductStrengthForm · routeLabelerProduct NDC
EverolimusEverolimus .75 mg/1TabletOralAscend Laboratories, LLC67877-720
EverolimusEverolimus .5 mg/1TabletOralAscend Laboratories, LLC67877-719
EverolimusEverolimus 1 mg/1TabletOralAscend Laboratories, LLC67877-721

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