Prescription drug · ANDA
Torpenz (Everolimus) NDC 0245-0825
Everolimus 10 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0245-0825-04 | 00245082504 | 28 BLISTER PACK in 1 CARTON (0245-0825-04) / 1 TABLET in 1 BLISTER PACK (0245-0825-89)Marketed from Oct 21, 2025 | |
| 0245-0825-30 | 00245082530 | 30 TABLET in 1 BOTTLE (0245-0825-30)Marketed from Jun 24, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Torpenz
- Generic name (nonproprietary)
- everolimus
- Active ingredients
- Everolimus — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0245
- 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 0245-0825_53e82eaf-5985-55b3-e063-6394a90a673aSPL ID 53e82eaf-5985-55b3-e063-6394a90a673aSPL set ID 4c0075dd-a0a8-4dc4-be32-1be8383fbbdcRxCUI 845507, 845515, 998189, 1119400, 2685202, 2685204, 2685206, 2685208UNII 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
N400245082504followed by a unit qualifier and the quantityPackage 00245-0825-04. 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)
1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer TORPENZ tablets are 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. TORPENZ (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 renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) Adult and pediatric patient…
Excerpt only. Read the full label for complete information.
About NDC 0245-0825
- What is NDC 0245-0825?
- 0245-0825 is the product NDC for Torpenz (everolimus), Everolimus 10 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Torpenz (Everolimus).
- What is the active ingredient?
- Everolimus.
- Who is the labeler?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Torpenz?
- 3 other product NDCs are listed under this name. See all Torpenz NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Torpenz products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Torpenzeverolimus | Everolimus 2.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0822 | 00245-0822-0400245-0822-30 |
| Torpenzeverolimus | Everolimus 5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0823 | 00245-0823-0400245-0823-30 |
| Torpenzeverolimus | Everolimus 7.5 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0245-0824 | 00245-0824-0400245-0824-30 |
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 2.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-254 |
| Everolimus | Everolimus 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-255 |
| Everolimus | Everolimus 7.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-256 |
| Everolimus | Everolimus 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-257 |
| 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 7.5 mg/1 | TabletOral | Biocon Pharma Inc. | 70377-012 |
| 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 |