Prescription drug · NDA
Afinitor Disperz (Everolimus) NDC 0078-0627
Everolimus 3 mg/1 · Tablet, For suspension · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0627-51 | 00078062751 | 28 BLISTER PACK in 1 CARTON (0078-0627-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61)Marketed from Aug 29, 2012 |
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)
- Afinitor DisperzSuffix: Disperz
- Generic name (nonproprietary)
- everolimus
- Active ingredients
- Everolimus — 3 mg/1
- Dosage form
- Tablet, For suspension
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203985
- 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 0078-0627_b808a4e0-23a8-40c8-834d-b31cd642febeSPL ID b808a4e0-23a8-40c8-834d-b31cd642febeSPL set ID 2150f73a-179b-4afc-b8ce-67c85cc72f04RxCUI 845507, 845512, 845515, 845518, 998189, 998191, 1119400, 1119402, 1308428, 1308430, 1308432, 1310138, 1310144, 1310147UNII 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
N400078062751followed by a unit qualifier and the quantityPackage 00078-0627-51. 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)
AFINITOR is 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: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced renal cell carcinoma (RCC) after failure of treat…
Excerpt only. Read the full label for complete information.
About NDC 0078-0627
- What is NDC 0078-0627?
- 0078-0627 is the product NDC for Afinitor Disperz (everolimus), Everolimus 3 mg/1 tablet, for suspension, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Afinitor Disperz (Everolimus).
- What is the active ingredient?
- Everolimus.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Afinitor Disperz?
- 2 other product NDCs are listed under this name. See all Afinitor Disperz NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Afinitor Disperz products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Afinitor Disperzeverolimus | Everolimus 2 mg/1 | Tablet, For suspensionOral | Novartis Pharmaceuticals Corporation | 0078-0626 | 00078-0626-51 |
| Afinitor Disperzeverolimus | Everolimus 5 mg/1 | Tablet, For suspensionOral | Novartis Pharmaceuticals Corporation | 0078-0628 | 00078-0628-51 |
Other NDCs under NDA 203985
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 |
|---|---|---|---|---|
| Afinitor Disperzeverolimus | Everolimus 2 mg/1 | Tablet, For suspensionOral | Novartis Pharmaceuticals Corporation | 0078-0626 |
| Afinitor Disperzeverolimus | Everolimus 5 mg/1 | Tablet, For suspensionOral | Novartis Pharmaceuticals Corporation | 0078-0628 |