Prescription drug · NDA
Zortress (Everolimus) NDC 0078-0417
Everolimus .25 mg/1 · Tablet · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0417-20 | 00078041720 | 60 BLISTER PACK in 1 BOX (0078-0417-20) / 1 TABLET in 1 BLISTER PACK (0078-0417-61)Marketed from Apr 22, 2010 |
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)
- Zortress
- Generic name (nonproprietary)
- everolimus
- Active ingredients
- Everolimus — .25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021560
- 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 0078-0417_ade28559-5fac-4dfd-a56c-c453ceb9e30bSPL ID ade28559-5fac-4dfd-a56c-c453ceb9e30b
- 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
N400078041720followed by a unit qualifier and the quantityPackage 00078-0417-20. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0078-0417
- What is NDC 0078-0417?
- 0078-0417 is the product NDC for Zortress (everolimus), Everolimus .25 mg/1 tablet, 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?
- Zortress (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 Zortress?
- 3 other product NDCs are listed under this name. See all Zortress NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zortress products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zortresseverolimus | Everolimus .5 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0414 | 00078-0414-20 |
| Zortresseverolimus | Everolimus 1 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0422 | 00078-0422-20 |
| Zortresseverolimus | Everolimus .75 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0415 | 00078-0415-20 |
Other NDCs under NDA 021560
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 |
|---|---|---|---|---|
| Zortresseverolimus | Everolimus .5 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0414 |
| Zortresseverolimus | Everolimus 1 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0422 |
| Zortresseverolimus | Everolimus .75 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0415 |