Turalio

Product NDC
65597-402
11-digit product format
655970402
Labeler code
65597
Product ID
65597-402_591b9371-dac1-46ff-8ecd-070daf2bd8aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pexidartinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Daiichi Sankyo, Inc.
Application
NDA211810
Marketing category
NDA
Marketing start
2019-08-02
Marketing end
0000-00-00
Substance
PEXIDARTINIB HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-402-20EA - Each65597-402755e086a-dc1a-435d-8975-2865f8abd2c812019-09-05
65597-402-28EA - Each65597-402d20b2e3e-d738-4ae2-afa2-85ce84575b0b12019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65597-402-20655970402201 BOTTLE in 1 CARTON (65597-402-20) > 120 CAPSULE in 1 BOTTLE1 bottle2019-08-020000-00-00NoNoCurrent
65597-402-28655970402281 BOTTLE in 1 CARTON (65597-402-28) > 28 CAPSULE in 1 BOTTLE1 bottle2019-08-020000-00-00NoNoCurrent