FDA.reportPublic FDA data

TIBSOVO

Product NDC
72694-617
11-digit product format
726940617
Labeler code
72694
Product ID
72694-617_190606ed-cb7f-411b-8548-cc2f98e57819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivosidenib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Servier Pharmaceutical LLC
Application
NDA211192
Marketing category
NDA
Marketing start
2021-10-19
Substance
IVOSIDENIB
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Isocitrate Dehydrogenase 1 Inhibitor [EPC], Isocitrate Dehydrogenase 1 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
TIBSOVO
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVOSIDENIB250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ2PCN8MAM6
Rxcui2049878, 2049884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2f1c3902-0b80-4dc0-a4fb-9c9c65ead741Product name120220309
72571337-a22c-4828-93a1-f00535d62549Product name120180914

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72694-617-60TIBSOVO60 in 1 BOTTLETABLET, FILM COATED6011
72694-617-60TIBSOVO1 in 1 CARTONTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72694-617-60EA - Each72694-617d2db39b5-92b8-43cf-8aaf-d29144f93d6f12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72694-617TIBSOVO (IVOSIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICAL LLC]10Current NDC, Legacy NDC, 2 package rows20240921_65d254c0-67ad-42c4-b972-ad463b755b2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049878ivosidenib 250 MG Oral TabletPSN65d254c0-67ad-42c4-b972-ad463b755b2d11
2049884TIBSOVO 250 MG Oral TabletPSN65d254c0-67ad-42c4-b972-ad463b755b2d11
2049884ivosidenib 250 MG Oral Tablet [Tibsovo]SBD65d254c0-67ad-42c4-b972-ad463b755b2d11
2049878ivosidenib 250 MG Oral TabletSCD65d254c0-67ad-42c4-b972-ad463b755b2d11
2049884Tibsovo 250 MG Oral TabletSY65d254c0-67ad-42c4-b972-ad463b755b2d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72694-617-60726940617601 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-10-190000-00-00NoNoCurrent