Prescription drug · ANDA
Everolimus NDC 51991-821
Everolimus 2.5 mg/1 · Tablet · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-821-28 | 51991082128 | 4 BLISTER PACK in 1 CARTON (51991-821-28) / 7 TABLET in 1 BLISTER PACK (51991-821-99)Marketed from Mar 5, 2021 | |
| 51991-821-33 | 51991082133 | 30 TABLET in 1 BOTTLE (51991-821-33)Marketed from Jun 5, 2023 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- 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 51991-821_fade73fb-a367-4c53-83dd-1352c3ad807bSPL ID fade73fb-a367-4c53-83dd-1352c3ad807bSPL set ID 01f7b5fb-be0d-4adf-acd2-6899018de966RxCUI 845507, 845515, 998189, 1119400, 1308428, 1308430, 1308432UNII 9HW64Q8G6GUPC 0351991822332, 0351991823339, 0351991824336, 0351991821335
- 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
N451991082128followed by a unit qualifier and the quantityPackage 51991-0821-28. 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. INDICATIONS AND USAGE 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 progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced re…
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 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 2.5 mg/1 | TabletOral | Natco Pharma Limited | 63850-0058 |
| 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 |