Prescription drug · ANDA
Everolimus NDC 67877-718
Everolimus .25 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-718-31 | 67877071831 | 6 BLISTER PACK in 1 CARTON (67877-718-31) / 10 TABLET in 1 BLISTER PACK (67877-718-33)Marketed from Nov 27, 2021 | |
| 67877-718-60 | 67877071860 | 60 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
- Labeler
- Ascend Laboratories, LLC
- 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
N467877071831followed by a unit qualifier and the quantityPackage 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.
Other NDCs under ANDA 214138
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Everolimus | Everolimus .75 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-720 |
| Everolimus | Everolimus .5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-719 |
| Everolimus | Everolimus 1 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-721 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.