FDA.reportPublic FDA data

Turalio

Product NDC
65597-407
11-digit product format
655970407
Labeler code
65597
Product ID
65597-407_00774850-56e9-4fb9-85e8-586967a9a5f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pexidartinib hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Daiichi Sankyo Inc.
Application
NDA211810
Marketing category
NDA
Marketing start
2023-02-01
Substance
PEXIDARTINIB HYDROCHLORIDE
Active strength
125 mg/1
Pharmacologic classes
Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], Tyrosine Kinase Inhibitors [MoA], UGT1A1 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
Turalio
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PEXIDARTINIB HYDROCHLORIDE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYS6WAI3XN7
Rxcui2626397, 2626399

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4aeb276-3bed-4d47-89b8-a169f1209705Product name120190820

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65597-407-20Turalio120 in 1 BOTTLECAPSULE1208
65597-407-20Turalio1 in 1 CARTONCAPSULE18
65597-407-28Turalio1 in 1 CARTONCAPSULE18
65597-407-28Turalio28 in 1 BOTTLECAPSULE288

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-407-20EA - Each65597-407dae7bba2-e029-464b-bbde-e8afd62d1c3412023-01-09
65597-407-28EA - Each65597-40722499dc0-8545-4948-9ae4-79e0df6e1b7712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65597-407TURALIO (PEXIDARTINIB HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO INC.]8Current NDC, 4 package rows20250119_7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2626397pexidartinib 125 MG Oral CapsulePSN7b0ec4bf-b2ac-49ee-96af-7740ad3f2e168
2626399Turalio 125 MG Oral CapsulePSN7b0ec4bf-b2ac-49ee-96af-7740ad3f2e168
2626399pexidartinib 125 MG Oral Capsule [Turalio]SBD7b0ec4bf-b2ac-49ee-96af-7740ad3f2e168
2626397pexidartinib 125 MG Oral CapsuleSCD7b0ec4bf-b2ac-49ee-96af-7740ad3f2e168
2626399Turalio 125 MG Oral CapsuleSY7b0ec4bf-b2ac-49ee-96af-7740ad3f2e168

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65597-407-20655970407201 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE1 bottle2023-02-01NoNoHistorical
65597-407-28655970407281 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE1 bottle2023-02-01NoNoHistorical