Prescription drug · NDA
Vijoice (Alpelisib) NDC 0078-1035
Kit · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-1035-02 | 00078103502 | 2 BLISTER PACK in 1 CARTON (0078-1035-02) / 1 KIT in 1 BLISTER PACK (0078-1035-61)Marketed from Apr 5, 2022 | |
| 0078-1035-92 | 00078103592 | 2 BLISTER PACK in 1 CARTON (0078-1035-92) / 1 KIT in 1 BLISTER PACK (0078-1035-94)Marketed from Apr 5, 2022 · Sample package |
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)
- Vijoice
- Generic name (nonproprietary)
- alpelisib
- Dosage form
- Kit
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215039
- Marketing start
- Listing expires
- Identifiers
- Product ID 0078-1035_6993f70f-a922-4520-9537-ec6cea3bd915SPL ID 6993f70f-a922-4520-9537-ec6cea3bd915SPL set ID 638069a4-aee0-46c9-9e21-54ad449c163cRxCUI 2169310, 2169316, 2169319, 2598459, 2598461, 2598463, 2598464, 2598465, 2598466, 2598467, 2598469, 2598470, 2680135, 2680138, 2680139, 2680140UNII 08W5N2C97Q
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400078103502followed by a unit qualifier and the quantityPackage 00078-1035-02. 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)
VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VIJOICE is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. This indication is approved under accelera…
Excerpt only. Read the full label for complete information.
About NDC 0078-1035
- What is NDC 0078-1035?
- 0078-1035 is the product NDC for Vijoice (alpelisib) kit, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vijoice (Alpelisib).
- 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 Vijoice?
- 3 other product NDCs are listed under this name. See all Vijoice NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vijoice products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vijoicealpelisib | Alpelisib 50 mg/1 | GranuleOral | Novartis Pharmaceuticals Corporation | 0078-1175 | 00078-1175-51 |
| Vijoicealpelisib | Alpelisib 50 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1021 | 00078-1021-8400078-1021-91 |
| Vijoicealpelisib | Alpelisib 125 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1028 | 00078-1028-8400078-1028-91 |
Other NDCs under NDA 215039
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 |
|---|---|---|---|---|
| Vijoicealpelisib | Alpelisib 50 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1021 |
| Vijoicealpelisib | Alpelisib 125 mg/1 | TabletOral | Novartis Pharmaceuticals Corporation | 0078-1028 |