FDA.reportPublic FDA data

VORANIGO

Product NDC
72694-728
11-digit product format
726940728
Labeler code
72694
Product ID
72694-728_a5229004-7c72-421b-a4ea-2830ee872d20
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
40 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VORANIGO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORASIDENIB40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii789Q85GA8P
Rxcui2690653, 2690659, 2690661, 2690663

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ce9dac3-8c0e-4661-a0c5-1919818988a2Product name120250312

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72694-728-40VORANIGO30 in 1 BOTTLETABLET, FILM COATED304
72694-728-40VORANIGO1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72694-728-40EA - Each72694-728b6be705e-bb7f-411e-bc20-38f24a05741e12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72694-728VORANIGO (VORASIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICALS LLC]4Current NDC, 2 package rows20250410_31405fee-55b7-4857-987e-2724ee76be84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2690659Voranigo 10 MG Oral TabletPSN31405fee-55b7-4857-987e-2724ee76be844
2690663Voranigo 40 MG Oral TabletPSN31405fee-55b7-4857-987e-2724ee76be844
2690653vorasidenib 10 MG Oral TabletPSN31405fee-55b7-4857-987e-2724ee76be844
2690661vorasidenib 40 MG Oral TabletPSN31405fee-55b7-4857-987e-2724ee76be844
2690659vorasidenib 10 MG Oral Tablet [Voranigo]SBD31405fee-55b7-4857-987e-2724ee76be844
2690663vorasidenib 40 MG Oral Tablet [Voranigo]SBD31405fee-55b7-4857-987e-2724ee76be844
2690653vorasidenib 10 MG Oral TabletSCD31405fee-55b7-4857-987e-2724ee76be844
2690661vorasidenib 40 MG Oral TabletSCD31405fee-55b7-4857-987e-2724ee76be844
2690659Voranigo 10 MG Oral TabletSY31405fee-55b7-4857-987e-2724ee76be844
2690663Voranigo 40 MG Oral TabletSY31405fee-55b7-4857-987e-2724ee76be844
2690653vorasidenib (as vorasidenib citrate) 10 MG Oral TabletSY31405fee-55b7-4857-987e-2724ee76be844
2690661vorasidenib (as vorasidenib citrate) 40 MG Oral TabletSY31405fee-55b7-4857-987e-2724ee76be844

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72694-728-40726940728401 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-08-07NoNoHistorical