Prescription drug · ANDA
Everolimus NDC 70377-012
Everolimus 7.5 mg/1 · Tablet · Oral · Biocon Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-012-11 | 70377001211 | 30 TABLET in 1 BOTTLE (70377-012-11)Marketed from Jun 8, 2023 | |
| 70377-012-22 | 70377001222 | 4 BLISTER PACK in 1 CARTON (70377-012-22) / 7 TABLET in 1 BLISTER PACKMarketed from Oct 1, 2021 | |
| 70377-012-23 | 70377001223 | 4 BLISTER PACK in 1 CARTON (70377-012-23) / 7 TABLET in 1 BLISTER PACKMarketed from May 17, 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
- Biocon Pharma Inc.
- 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 70377-012_4e63b36e-3d75-b3b0-42b6-f2f3c1ddf4d0SPL ID 4e63b36e-3d75-b3b0-42b6-f2f3c1ddf4d0SPL set ID 5fb55800-f322-6bb6-9dde-622925ef28bdRxCUI 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
N470377001211followed by a unit qualifier and the quantityPackage 70377-0012-11. 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 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 |
| Everolimus | Everolimus 7.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-256 |