Prescription drug · NDA
Itovebi (Inavolisib) NDC 50242-079
Inavolisib 9 mg/1 · Tablet, Film coated · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-079-08 | 50242007908 | 1 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 14, 2024 | |
| 50242-079-86 | 50242007986 | 1 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLEMarketed from Jan 6, 2025 · Sample package |
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)
- Itovebi
- Generic name (nonproprietary)
- inavolisib
- Active ingredients
- Inavolisib — 9 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219249
- Marketing start
- Listing expires
- Other FDA classes
- Phosphoinositide 3-Kinase alpha Inhibitors (Mechanism)
- Identifiers
- Product ID 50242-079_dd6ab36d-21fa-4513-a9d1-0867ca4420e8SPL ID dd6ab36d-21fa-4513-a9d1-0867ca4420e8SPL set ID 5de59f5b-e5db-410f-b692-658686ef4107RxCUI 2695427, 2695433, 2695435, 2695437UNII L4C1UY2NYH
- Pharmacologic class
- Kinase Inhibitor
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
N450242007908followed by a unit qualifier and the quantityPackage 50242-0079-08. 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)
ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic b…
Excerpt only. Read the full label for complete information.
About NDC 50242-079
- What is NDC 50242-079?
- 50242-079 is the product NDC for Itovebi (inavolisib), Inavolisib 9 mg/1 tablet, film coated, listed with the FDA by Genentech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Itovebi (Inavolisib).
- What is the active ingredient?
- Inavolisib.
- Who is the labeler?
- Genentech, Inc., NDC labeler code 50242. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Itovebi?
- 1 other product NDC are listed under this name. See all Itovebi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Itovebi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Itovebiinavolisib | Inavolisib 3 mg/1 | Tablet, Film coatedOral | Genentech, Inc. | 50242-084 | 50242-0084-08 |
Other NDCs under NDA 219249
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 |
|---|---|---|---|---|
| Itovebiinavolisib | Inavolisib 3 mg/1 | Tablet, Film coatedOral | Genentech, Inc. | 50242-084 |