Prescription drug · ANDA
Everolimus NDC 63850-0058
Everolimus 2.5 mg/1 · Tablet · Oral · Natco Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63850-0058-1 | 63850005801 | 4 BLISTER PACK in 1 CARTON (63850-0058-1) / 7 TABLET in 1 BLISTER PACKMarketed from Mar 5, 2021 | |
| 63850-0058-4 | 63850005804 | 30 TABLET in 1 BOTTLE (63850-0058-4)Marketed from May 26, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Natco Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205426
- 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 63850-0058_6df3819e-2d45-4030-a4af-6caeccb8a471SPL ID 6df3819e-2d45-4030-a4af-6caeccb8a471SPL set ID e3dbbc24-7e55-4069-a305-e2cded2db641RxCUI 845507, 845515, 998189, 1119400UNII 9HW64Q8G6GUPC 0363850006128, 0363850005817, 0363850006111, 0363850005923, 0363850005824, 0363850005916, 0363850006012
- 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
N463850005801followed by a unit qualifier and the quantityPackage 63850-0058-01. 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: Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. ( 1.3 ) Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) Everolimus tablets are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) 1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer Everolimus tablets are indicated for the treatment of postmenopausal women wi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205426
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 10 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-824 |
| Everolimus | Everolimus 2.5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-821 |
| Everolimus | Everolimus 5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-822 |
| Everolimus | Everolimus 7.5 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-823 |
| Everolimus | Everolimus 5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0059 |
| Everolimus | Everolimus 7.5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0060 |
| Everolimus | Everolimus 10 mg/1 | TabletOral | Natco Pharma Limited | 63850-0061 |
| Yulithiraeverolimus | Everolimus 2.5 mg/1 | TabletOral | CivicaScript, LLC | 82249-610 |
| Yulithiraeverolimus | Everolimus 5 mg/1 | TabletOral | CivicaScript, LLC | 82249-611 |
| Yulithiraeverolimus | Everolimus 7.5 mg/1 | TabletOral | CivicaScript, LLC | 82249-612 |
| Yulithiraeverolimus | Everolimus 10 mg/1 | TabletOral | CivicaScript, LLC | 82249-613 |