Home NDC 50242-079 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50242-079-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50242-079-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50242-079-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50242-079-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50242-079-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50242-079-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50242-079-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50242-079-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50242-079-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50242-079-01 ad56d346431e…cc804d4bbf1e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219249-001 ITOVEBI INAVOLISIB 3MG TABLET / ORAL RLD 2024-10-10 N219249-002 ITOVEBI INAVOLISIB 9MG TABLET / ORAL RLD, RS 2024-10-10
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219249-001 8242104 2030-09-27 Drug substance, Drug product 2024-11-08 N219249-001 8343955 2030-09-27 U-4024 2024-11-08 N219249-001 10851091 2036-07-01 Drug substance, Drug product 2024-11-08 N219249-001 11760753 2036-07-01 U-4024 2024-11-08 N219249-001 9650393 2036-07-01 U-4024 Drug substance, Drug product 2024-11-08 N219249-001 11028100 2038-04-26 Drug substance, Drug product 2024-11-08 N219249-001 12410189 2038-06-14 U-4024 2025-10-07 N219249-002 8242104 2030-09-27 Drug substance, Drug product 2024-11-08 N219249-002 8343955 2030-09-27 U-4024 2024-11-08 N219249-002 10851091 2036-07-01 Drug substance, Drug product 2024-11-08 N219249-002 11760753 2036-07-01 U-4024 2024-11-08 N219249-002 9650393 2036-07-01 U-4024 Drug substance, Drug product 2024-11-08 N219249-002 11028100 2038-04-26 Drug substance, Drug product 2024-11-08 N219249-002 12410189 2038-06-14 U-4024 2025-10-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219249-001 NCE 2029-10-10 N219249-002 NCE 2029-10-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219249-001 ITOVEBI 3MG TABLET / ORAL RLD 2024-10-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219249-002 ITOVEBI 9MG TABLET / ORAL RLD, RS 2024-10-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 102 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219249-001 8242104 2030-09-27 Drug substance, Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-001 8343955 2030-09-27 U-4024 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-001 10851091 2036-07-01 Drug substance, Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-001 11760753 2036-07-01 U-4024 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-001 9650393 2036-07-01 U-4024 Drug substance, Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-001 11028100 2038-04-26 Drug substance, Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-001 12410189 2038-06-14 U-4024 2025-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 8242104 2030-09-27 Drug substance, Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 8343955 2030-09-27 U-4024 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 10851091 2036-07-01 Drug substance, Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 11760753 2036-07-01 U-4024 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 9650393 2036-07-01 U-4024 Drug substance, Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 11028100 2038-04-26 Drug substance, Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 12410189 2038-06-14 U-4024 2025-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 8242104 2030-09-27 Drug substance, Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 8343955 2030-09-27 U-4024 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 10851091 2036-07-01 Drug substance, Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 11760753 2036-07-01 U-4024 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 9650393 2036-07-01 U-4024 Drug substance, Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 11028100 2038-04-26 Drug substance, Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 12410189 2038-06-14 U-4024 2025-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 8242104 2030-09-27 Drug substance, Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 8343955 2030-09-27 U-4024 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 10851091 2036-07-01 Drug substance, Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 11760753 2036-07-01 U-4024 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 9650393 2036-07-01 U-4024 Drug substance, Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 11028100 2038-04-26 Drug substance, Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 12410189 2038-06-14 U-4024 2025-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219249-001 8242104 2030-09-27 Drug substance, Drug product 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-001 8343955 2030-09-27 U-4024 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-001 10851091 2036-07-01 Drug substance, Drug product 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-001 11760753 2036-07-01 U-4024 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-001 9650393 2036-07-01 U-4024 Drug substance, Drug product 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-001 11028100 2038-04-26 Drug substance, Drug product 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-002 8242104 2030-09-27 Drug substance, Drug product 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-002 8343955 2030-09-27 U-4024 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-002 10851091 2036-07-01 Drug substance, Drug product 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-002 11760753 2036-07-01 U-4024 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-002 9650393 2036-07-01 U-4024 Drug substance, Drug product 2024-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-002 11028100 2038-04-26 Drug substance, Drug product 2024-11-08 6a471c1ec25d…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219249-001 NCE 2029-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219249-002 NCE 2029-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-001 NCE 2029-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219249-002 NCE 2029-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219249-001 NCE 2029-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219249-002 NCE 2029-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219249-001 NCE 2029-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219249-002 NCE 2029-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219249-001 NCE 2029-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219249-002 NCE 2029-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219249-001 NCE 2029-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219249-002 NCE 2029-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219249-001 NCE 2029-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219249-002 NCE 2029-10-10 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219249-001 NCE 2029-10-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219249-002 NCE 2029-10-10 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Itovebi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INAVOLISIB 9 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L4C1UY2NYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2695427 Internal RxNorm lookup 2695433 Internal RxNorm lookup 2695435 Internal RxNorm lookup 2695437 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50242-079-08 Itovebi 1 in 1 CARTON TABLET, FILM COATED 1 10 50242-079-08 Itovebi 28 in 1 BOTTLE TABLET, FILM COATED 28 10 50242-079-86 Itovebi 28 in 1 BOTTLE TABLET, FILM COATED 28 10 50242-079-86 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 50242-079 ITOVEBI (INAVOLISIB) TABLET, FILM COATED [GENENTECH, INC.] 4 Current NDC, 4 package rows 20250124_5de59f5b-e5db-410f-b692-658686ef4107.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50242-079-08 50242007908 1 BOTTLE in 1 CARTON (50242-079-08) / 28 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2024-10-14 No No Current 50242-079-86 50242007986 1 BOTTLE in 1 CARTON (50242-079-86) / 28 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-01-06 Yes No Current