FDA.reportPublic FDA data

Itovebi

Product NDC
50242-079
11-digit product format
502420079
Labeler code
50242
Product ID
50242-079_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
9 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
IngredientStrength
INAVOLISIB9 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4C1UY2NYH
Rxcui2695427, 2695433, 2695435, 2695437

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fde47951-a289-4bd2-ad3f-689922fc5dd6Product name120250505

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-079-08Itovebi1 in 1 CARTONTABLET, FILM COATED110
50242-079-08Itovebi28 in 1 BOTTLETABLET, FILM COATED2810
50242-079-86Itovebi28 in 1 BOTTLETABLET, FILM COATED2810
50242-079-86Itovebi1 in 1 CARTONTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-079-08EA - Each50242-07977fec707-e8c5-418a-acde-662c0ad91f3a12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-079ITOVEBI (INAVOLISIB) TABLET, FILM COATED [GENENTECH, INC.]4Current NDC, 4 package rows20250124_5de59f5b-e5db-410f-b692-658686ef4107.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695427inavolisib 3 MG Oral TabletPSN5de59f5b-e5db-410f-b692-658686ef410710
2695435inavolisib 9 MG Oral TabletPSN5de59f5b-e5db-410f-b692-658686ef410710
2695433Itovebi 3 MG Oral TabletPSN5de59f5b-e5db-410f-b692-658686ef410710
2695437Itovebi 9 MG Oral TabletPSN5de59f5b-e5db-410f-b692-658686ef410710
2695433inavolisib 3 MG Oral Tablet [Itovebi]SBD5de59f5b-e5db-410f-b692-658686ef410710
2695437inavolisib 9 MG Oral Tablet [Itovebi]SBD5de59f5b-e5db-410f-b692-658686ef410710
2695427inavolisib 3 MG Oral TabletSCD5de59f5b-e5db-410f-b692-658686ef410710
2695435inavolisib 9 MG Oral TabletSCD5de59f5b-e5db-410f-b692-658686ef410710
2695433Itovebi 3 MG Oral TabletSY5de59f5b-e5db-410f-b692-658686ef410710
2695437Itovebi 9 MG Oral TabletSY5de59f5b-e5db-410f-b692-658686ef410710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50242-079-08502420079081 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-10-14NoNoHistorical
50242-079-86502420079861 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-01-06YesNoHistorical