Prescription drug · ANDA
Everolimus NDC 70377-090
Everolimus 2 mg/1 · Tablet, For suspension · Oral · Biocon Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-090-11 | 70377009011 | 28 TABLET, FOR SUSPENSION in 1 BOTTLE (70377-090-11)Marketed from Jan 14, 2026 | |
| 70377-090-23 | 70377009023 | 4 BLISTER PACK in 1 CARTON (70377-090-23) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACKMarketed from Jan 14, 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 — 2 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Biocon Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217216
- 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 70377-090_7f7c486a-aefb-4798-aa9f-365799886a72SPL ID 7f7c486a-aefb-4798-aa9f-365799886a72SPL set ID 5b809dfe-c076-07c5-207e-178c3f0d32d3RxCUI 1308428, 1308430, 1308432UNII 9HW64Q8G6GUPC 0370377092114, 0370377090110, 0370377091117, 0370377091230, 0370377090233
- 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
N470377009011followed by a unit qualifier and the quantityPackage 70377-0090-11. 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 for oral suspension are kinase inhibitor 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 ) Everolimus tablets for oral suspension is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. ( 1.6 ) 1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) Everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with TSC f…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217216
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 3 mg/1 | Tablet, For suspensionOral | Biocon Pharma Inc. | 70377-091 |
| Everolimus | Everolimus 5 mg/1 | Tablet, For suspensionOral | Biocon Pharma Inc. | 70377-092 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.