Itovebi
- Product NDC
- 50242-084
- 11-digit product format
- 502420084
- Labeler code
- 50242
- Product ID
- 50242-084_dd6ab36d-21fa-4513-a9d1-0867ca4420e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Inavolisib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Genentech, Inc.
- Application
- NDA219249
- Marketing category
- NDA
- Marketing start
- 2024-10-14
- Substance
- INAVOLISIB
- Active strength
- 3 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Phosphoinositide 3-Kinase alpha Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Itovebi
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INAVOLISIB | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L4C1UY2NYH |
| Rxcui | 2695427, 2695433, 2695435, 2695437 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-084-08 | Itovebi | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 10 |
| 50242-084-08 | Itovebi | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-084 | ITOVEBI (INAVOLISIB) TABLET, FILM COATED [GENENTECH, INC.] | 4 | Current NDC, 2 package rows | 20250124_5de59f5b-e5db-410f-b692-658686ef4107.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-084-08 | 50242008408 | 1 BOTTLE in 1 CARTON (50242-084-08) / 28 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-10-14 | No | No | Historical |