Prescription drug · NDA
Zortress (Everolimus) NDC 0078-0415
Everolimus .75 mg/1 · Tablet · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0415-20 | 00078041520 | 60 BLISTER PACK in 1 BOX (0078-0415-20) / 1 TABLET in 1 BLISTER PACK (0078-0415-61)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 — .75 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 0078-0415_5b9ba6f0-1e1d-4b9c-9122-ad856284d7caSPL ID 5b9ba6f0-1e1d-4b9c-9122-ad856284d7caSPL set ID e082a024-7850-400b-a5c2-2a140612562aRxCUI 977427, 977431, 977434, 977436, 977438, 977440, 2056895, 2056897UNII 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
N400078041520followed by a unit qualifier and the quantityPackage 00078-0415-20. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney Transplant : at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids ( 1.1) Liver Transplant : Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids ( 1.2 , 5.5 ) Limitations of Use : Safety and efficacy have not been established in the following: Kidney transplant patients at high immunologic risk ( 1.3 ) Recipients of transplanted organs other than kidney or liver ( 1.3 , 5.7 ) Pediatric patients (less than 18 years) ( 1.3 ) 1.1 Prophylaxi…
Excerpt only. Read the full label for complete information.
About NDC 0078-0415
- What is NDC 0078-0415?
- 0078-0415 is the product NDC for Zortress (everolimus), Everolimus .75 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 1 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0422 | 00078-0422-20 |
| Zortresseverolimus | Everolimus .25 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0417 | 00078-0417-20 |
| Zortresseverolimus | Everolimus .5 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0414 | 00078-0414-20 |
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 .25 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0417 |
| Zortresseverolimus | Everolimus .5 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0414 |
| Zortresseverolimus | Everolimus 1 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-0422 |