Tibsovo

Product NDC
71334-100
11-digit product format
713340100
Labeler code
71334
Product ID
71334-100_7618e704-4d61-4af1-8a05-1f521db4f309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ivosidenib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Agios Pharmaceuticals, Inc.
Application
NDA211192
Marketing category
NDA
Marketing start
2018-07-20
Marketing end
2024-11-30
Substance
IVOSIDENIB
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71334-100-01EA - Each71334-1007157d946-573d-4985-843c-9924c806ac1112018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71334-100-017133401000160 TABLET, FILM COATED in 1 BOTTLE (71334-100-01) 2018-07-202024-11-30NoNoCurrent