Prescription drug · ANDA
Everolimus NDC 72603-256
Everolimus 7.5 mg/1 · Tablet · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-256-01 | 72603025601 | 30 TABLET in 1 BOTTLE (72603-256-01)Marketed from Oct 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 — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214182
- 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 72603-256_10865ecf-d37f-4062-ec4e-b8c8a9c36897SPL ID 10865ecf-d37f-4062-ec4e-b8c8a9c36897SPL set ID 5cfca904-b75c-5a39-8cb9-b99bb421bcebRxCUI 845507, 845515, 998189, 1119400UNII 9HW64Q8G6GUPC 0372603257014, 0372603256017, 0372603255010, 0372603254013
- 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
N472603025601followed by a unit qualifier and the quantityPackage 72603-0256-01. 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 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 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 Ever…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214182
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 | Biocon Pharma Inc. | 70377-012 |
| Everolimus | Everolimus 2.5 mg/1 | TabletOral | Biocon Pharma Inc. | 70377-010 |
| Everolimus | Everolimus 5 mg/1 | TabletOral | Biocon Pharma Inc. | 70377-011 |
| Everolimus | Everolimus 10 mg/1 | TabletOral | Biocon Pharma Inc. | 70377-013 |
| Torpenzeverolimus | Everolimus 2.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0822 |
| Torpenzeverolimus | Everolimus 5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0823 |
| Torpenzeverolimus | Everolimus 7.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0824 |
| Torpenzeverolimus | Everolimus 10 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0825 |
| Everolimus | Everolimus 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-257 |
| Everolimus | Everolimus 2.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-254 |
| Everolimus | Everolimus 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-255 |