Prescription drug · ANDA
everolimus NDC 82293-031
Everolimus 5 mg/1 · Tablet · Oral · Novugen Pharma (USA) LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82293-031-10 | 82293003110 | 28 TABLET in 1 BOTTLE (82293-031-10)Marketed from Mar 30, 2026 | |
| 82293-031-21 | 82293003121 | 4 BLISTER PACK in 1 CARTON (82293-031-21) / 7 TABLET in 1 BLISTER PACK (82293-031-20)Marketed from Mar 30, 2026 | |
| 82293-031-31 | 82293003131 | 1 POUCH in 1 CARTON (82293-031-31) / 3 BLISTER PACK in 1 POUCH / 10 TABLET in 1 BLISTER PACK (82293-031-30)Marketed from Mar 30, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novugen Pharma (USA) LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219955
- 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 82293-031_4ca7b927-0d89-0be6-e063-6394a90af200SPL ID 4ca7b927-0d89-0be6-e063-6394a90af200SPL set ID 67e62e26-448d-46ec-b5a1-00dc1b5e26c6RxCUI 845507, 845515, 998189, 1119400UNII 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
N482293003110followed by a unit qualifier and the quantityPackage 82293-0031-10. 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 .
Indications (excerpt from the label)
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, 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 renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) Everolimus tab…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219955
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 7.5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-032 |
| everolimus | Everolimus 2.5 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-030 |
| everolimus | Everolimus 10 mg/1 | TabletOral | Novugen Pharma (USA) LLC. | 82293-033 |