FDA.reportPublic FDA data

IBTROZI

Product NDC
84651-200
11-digit product format
846510200
Labeler code
84651
Product ID
84651-200_5154bda7-7ab4-4ad4-8fee-7fbe9ea692cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
taletrectinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Nuvation Bio Inc.
Application
NDA219713
Marketing category
NDA
Marketing start
2025-06-11
Substance
TALETRECTINIB ADIPATE
Active strength
272 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Proto-Oncogene Tyrosine-Protein Kinase ROS1 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBTROZI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALETRECTINIB ADIPATE272 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KLL51GNBG
Rxcui2716925, 2716931

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84651-200-30IBTROZI30 in 1 BOTTLECAPSULE304
84651-200-90IBTROZI90 in 1 BOTTLECAPSULE904
84651-200-90IBTROZI1 in 1 CARTONCAPSULE14
84651-200-93IBTROZI3 in 1 CARTONCAPSULE34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84651-200-30EA - Each84651-200ffd26c79-b28f-49bb-9685-65abaecb117012025-07-08
84651-200-93EA - Each84651-200474b578e-68b2-4adc-9f19-33e52aa25d8412025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2716931IBTROZI 200 MG Oral CapsulePSN51ac8e52-3269-4102-8dc8-dba22d82128c4
2716925taletrectinib 200 MG Oral CapsulePSN51ac8e52-3269-4102-8dc8-dba22d82128c4
2716931taletrectinib 200 MG Oral Capsule [Ibtrozi]SBD51ac8e52-3269-4102-8dc8-dba22d82128c4
2716925taletrectinib 200 MG Oral CapsuleSCD51ac8e52-3269-4102-8dc8-dba22d82128c4
2716931Ibtrozi 200 MG (as taletrectinib adipate 272 MG) Oral CapsuleSY51ac8e52-3269-4102-8dc8-dba22d82128c4
2716925taletrectinib 200 MG (as taletrectinib adipate 272 MG) Oral CapsuleSY51ac8e52-3269-4102-8dc8-dba22d82128c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84651-200-308465102003030 in 1 BOTTLEHistorical
84651-200-908465102009090 in 1 BOTTLEHistorical
84651-200-93846510200933 BOTTLE in 1 CARTON (84651-200-93) / 30 CAPSULE in 1 BOTTLE (84651-200-30) 3 bottle2025-06-13NoNoHistorical