VORANIGO

Product NDC: 72694-879
11-digit product format: 726940879
Labeler code: 72694
Product ID: 72694-879_ee016d13-6ef7-4e50-bb23-d8ece41d549d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vorasidenib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Servier Pharmaceuticals LLC
Application: NDA218784
Marketing category: NDA
Marketing start: 2024-08-07
Substance: VORASIDENIB
Active strength: 10 mg/1
Pharmacologic classes: Cytochrome P450 3A Inducers [MoA], Isocitrate Dehydrogenase 1 Inhibitor [EPC], Isocitrate Dehydrogenase 1 Inhibitors [MoA], Isocitrate Dehydrogenase 2 Inhibitor [EPC], Isocitrate Dehydrogenase 2 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
N218784-001	VORANIGO	VORASIDENIB	10MG	TABLET / ORAL		RLD	2024-08-06
N218784-002	VORANIGO	VORASIDENIB	40MG	TABLET / ORAL		RLD, RS	2024-08-06

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27
N218784-001	12433895	2034-07-11	U-4286		2025-10-22
N218784-001	9579324	2034-07-11		Drug substance	2024-08-27
N218784-001	11844758	2035-12-04	U-3977		2024-08-27
N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27
N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27
N218784-002	12433895	2034-07-11	U-4286		2025-10-22
N218784-002	9579324	2034-07-11		Drug substance	2024-08-27
N218784-002	11844758	2035-12-04	U-3977		2024-08-27
N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218784-001	NCE	2029-08-06
N218784-001	ODE-491	2031-08-06
N218784-002	NCE	2029-08-06
N218784-002	ODE-491	2031-08-06

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	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218784-001	VORANIGO	10MG	TABLET / ORAL	RLD	2024-08-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218784-002	VORANIGO	40MG	TABLET / ORAL	RLD, RS	2024-08-06	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 114 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	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-001	12433895	2034-07-11	U-4286		2025-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	12433895	2034-07-11	U-4286		2025-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	11844758	2035-12-04	U-3977		2024-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-001	12433895	2034-07-11	U-4286		2025-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	12433895	2034-07-11	U-4286		2025-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	11844758	2035-12-04	U-3977		2024-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-001	12433895	2034-07-11	U-4286		2025-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	12433895	2034-07-11	U-4286		2025-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	11844758	2035-12-04	U-3977		2024-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	12433895	2034-07-11	U-4286		2025-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	9579324	2034-07-11		Drug substance	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	11844758	2035-12-04	U-3977		2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	10172864	2034-07-11		Drug substance, Drug product	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	12433895	2034-07-11	U-4286		2025-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	9579324	2034-07-11		Drug substance	2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	11844758	2035-12-04	U-3977		2024-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	11345677	2039-01-16	U-3978	Drug substance, Drug product	2024-08-27	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218784-001	NCE	2029-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-001	ODE-491	2031-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	NCE	2029-08-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218784-002	ODE-491	2031-08-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218784-001	NCE	2029-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-001	ODE-491	2031-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	NCE	2029-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218784-002	ODE-491	2031-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218784-001	NCE	2029-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-001	ODE-491	2031-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	NCE	2029-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218784-002	ODE-491	2031-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	NCE	2029-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-001	ODE-491	2031-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	NCE	2029-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218784-002	ODE-491	2031-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218784-001	NCE	2029-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-001	ODE-491	2031-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	NCE	2029-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218784-002	ODE-491	2031-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	NCE	2029-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-001	ODE-491	2031-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	NCE	2029-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218784-002	ODE-491	2031-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	NCE	2029-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-001	ODE-491	2031-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	NCE	2029-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218784-002	ODE-491	2031-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	NCE	2029-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-001	ODE-491	2031-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-002	NCE	2029-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218784-002	ODE-491	2031-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-001	NCE	2029-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-001	ODE-491	2031-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-002	NCE	2029-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218784-002	ODE-491	2031-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218784-001	NCE	2029-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218784-001	ODE-491	2031-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218784-002	NCE	2029-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218784-002	ODE-491	2031-08-06	`5bbf6a4d5a75…`

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: VORANIGO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VORASIDENIB	10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ce9dac3-8c0e-4661-a0c5-1919818988a2	Product name	1	20250312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72694-879-10	VORANIGO	30 in 1 BOTTLE	TABLET, FILM COATED	30		4
72694-879-10	VORANIGO	1 in 1 CARTON	TABLET, FILM COATED	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72694-879-10	EA - Each	72694-879	612ceaba-d091-4afe-8ff1-6ab25ba96d24	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72694-879	VORANIGO (VORASIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICALS LLC]	4	Current NDC, 2 package rows	20250410_31405fee-55b7-4857-987e-2724ee76be84.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
789Q85GA8P	VORASIDENIB	1644545-52-7	VORASIDENIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2690659	Voranigo 10 MG Oral Tablet	PSN	31405fee-55b7-4857-987e-2724ee76be84	4
2690663	Voranigo 40 MG Oral Tablet	PSN	31405fee-55b7-4857-987e-2724ee76be84	4
2690653	vorasidenib 10 MG Oral Tablet	PSN	31405fee-55b7-4857-987e-2724ee76be84	4
2690661	vorasidenib 40 MG Oral Tablet	PSN	31405fee-55b7-4857-987e-2724ee76be84	4
2690659	vorasidenib 10 MG Oral Tablet [Voranigo]	SBD	31405fee-55b7-4857-987e-2724ee76be84	4
2690663	vorasidenib 40 MG Oral Tablet [Voranigo]	SBD	31405fee-55b7-4857-987e-2724ee76be84	4
2690653	vorasidenib 10 MG Oral Tablet	SCD	31405fee-55b7-4857-987e-2724ee76be84	4
2690661	vorasidenib 40 MG Oral Tablet	SCD	31405fee-55b7-4857-987e-2724ee76be84	4
2690659	Voranigo 10 MG Oral Tablet	SY	31405fee-55b7-4857-987e-2724ee76be84	4
2690663	Voranigo 40 MG Oral Tablet	SY	31405fee-55b7-4857-987e-2724ee76be84	4
2690653	vorasidenib (as vorasidenib citrate) 10 MG Oral Tablet	SY	31405fee-55b7-4857-987e-2724ee76be84	4
2690661	vorasidenib (as vorasidenib citrate) 40 MG Oral Tablet	SY	31405fee-55b7-4857-987e-2724ee76be84	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72694-879-10	72694087910	1 BOTTLE in 1 CARTON (72694-879-10) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-08-07	No	No	Current