Itovebi

Product NDC: 50242-084
Requested package NDC: 50242-084-08
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219249-001	ITOVEBI	3MG	TABLET / ORAL	RLD	2024-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	ITOVEBI	9MG	TABLET / ORAL	RLD, RS	2024-10-10	`caaa826d4ba7…`
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 4 · 130 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219249-001	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-001	8343955	2030-09-27	U-4024		2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-001	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-001	11760753	2036-07-01	U-4024		2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-001	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-001	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-001	12410189	2038-06-14	U-4024		2025-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	8343955	2030-09-27	U-4024		2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	11760753	2036-07-01	U-4024		2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	12410189	2038-06-14	U-4024		2025-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219249-001	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-001	8343955	2030-09-27	U-4024		2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-001	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-001	11760753	2036-07-01	U-4024		2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-001	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-001	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-001	12410189	2038-06-14	U-4024		2025-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	8242104	2030-09-27		Drug substance, Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	8343955	2030-09-27	U-4024		2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	10851091	2036-07-01		Drug substance, Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	11760753	2036-07-01	U-4024		2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	9650393	2036-07-01	U-4024	Drug substance, Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	11028100	2038-04-26		Drug substance, Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	12410189	2038-06-14	U-4024		2025-10-07	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219249-001	NCE	2029-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219249-002	NCE	2029-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219249-001	NCE	2029-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219249-002	NCE	2029-10-10	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5de59f5b-e5db-410f-b692-658686ef4107	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fde47951-a289-4bd2-ad3f-689922fc5dd6	Product name	1	20250505

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50242-084-08	EA - Each	50242-084	e6342c4a-f81c-47d0-ada4-16e9ac3bd23a	1	2024-11-05

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

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Itovebi	INAVOLISIB	Genentech, Inc.	5de59f5b-e5db-410f-b692-658686ef4107	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219249 application number: NDA219249 ndc (package): 50242-084-08 ndc (product): 50242-084 ndc11 (package): 50242008408

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2695427	inavolisib 3 MG Oral Tablet	PSN	5de59f5b-e5db-410f-b692-658686ef4107	10
2695435	inavolisib 9 MG Oral Tablet	PSN	5de59f5b-e5db-410f-b692-658686ef4107	10
2695433	Itovebi 3 MG Oral Tablet	PSN	5de59f5b-e5db-410f-b692-658686ef4107	10
2695437	Itovebi 9 MG Oral Tablet	PSN	5de59f5b-e5db-410f-b692-658686ef4107	10
2695433	inavolisib 3 MG Oral Tablet [Itovebi]	SBD	5de59f5b-e5db-410f-b692-658686ef4107	10
2695437	inavolisib 9 MG Oral Tablet [Itovebi]	SBD	5de59f5b-e5db-410f-b692-658686ef4107	10
2695427	inavolisib 3 MG Oral Tablet	SCD	5de59f5b-e5db-410f-b692-658686ef4107	10
2695435	inavolisib 9 MG Oral Tablet	SCD	5de59f5b-e5db-410f-b692-658686ef4107	10
2695433	Itovebi 3 MG Oral Tablet	SY	5de59f5b-e5db-410f-b692-658686ef4107	10
2695437	Itovebi 9 MG Oral Tablet	SY	5de59f5b-e5db-410f-b692-658686ef4107	10

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	Current