FDA.reportPublic FDA data

VITRAKVI

Product NDC
50419-392
11-digit product format
504190392
Labeler code
50419
Product ID
50419-392_0e3ba6e7-af8d-4840-9409-a537a09e1263
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAROTRECTINIB
Dosage form
SOLUTION, CONCENTRATE
Route
OROPHARYNGEAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA211710
Marketing category
NDA
Marketing start
2019-07-26
Substance
LAROTRECTINIB
Active strength
20 mg/mL
Pharmacologic classes
Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases 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
VITRAKVI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAROTRECTINIB20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPF9462I9HX
Rxcui2105633, 2105645, 2105649, 2105653, 2105655, 2105657

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
0fc8d6a0-e17e-438b-8b82-328781db0b4cProduct name220190320
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50419-392-012024-01-30C16284748780-11030e365-05f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 2018
50419-392-012024-01-30C16284748780-11030e365-05f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 2018
50419-392-012024-01-30C16284748780-11030e365-05f3-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-392-01VITRAKVI100 mL in 1 BOTTLESOLUTION, CONCENTRATE10021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-392-01ML - Milliliter50419-3920163b18b-b83b-4d8e-9087-dbe4b7e5818312019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-392VITRAKVI (LAROTRECTINIB) CAPSULE VITRAKVI (LAROTRECTINIB) SOLUTION, CONCENTRATE [BAYER HEALTHCARE PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20250506_0c8ca614-58b2-4aa4-83d3-0387a8f782fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2105633larotrectinib 100 MG Oral CapsulePSN0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105649larotrectinib 20 MG in 1 mL Oral SolutionPSN0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105655larotrectinib 25 MG Oral CapsulePSN0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105645VITRAKVI 100 MG Oral CapsulePSN0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105653VITRAKVI 20 MG in 1 mL Oral SolutionPSN0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105657VITRAKVI 25 MG Oral CapsulePSN0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105645larotrectinib 100 MG Oral Capsule [Vitrakvi]SBD0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105653larotrectinib 20 MG/ML Oral Solution [Vitrakvi]SBD0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105657larotrectinib 25 MG Oral Capsule [Vitrakvi]SBD0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105633larotrectinib 100 MG Oral CapsuleSCD0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105649larotrectinib 20 MG/ML Oral SolutionSCD0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105655larotrectinib 25 MG Oral CapsuleSCD0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105633larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsuleSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105649larotrectinib 20 MG (as 24.6 MG larotrectinib sulfate) per 1 ML Oral SolutionSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105649larotrectinib 20 MG per 1 ML Oral SolutionSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105655larotrectinib 25 MG (as 30.7 MG larotrectinib sulfate) Oral CapsuleSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105645Vitrakvi 100 MG (as 123 MG larotrectinib sulfate) Oral CapsuleSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105645Vitrakvi 100 MG Oral CapsuleSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105653Vitrakvi 20 MG (as 24.6 MG larotrectinib sulfate) per 1 mL Oral SolutionSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105653Vitrakvi 20 MG per 1 mL Oral SolutionSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105653Vitrakvi 20 MG/ML Oral SolutionSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105657Vitrakvi 25 MG (as 30.7 MG larotrectinib sulfate) Oral CapsuleSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21
2105657Vitrakvi 25 MG Oral CapsuleSY0c8ca614-58b2-4aa4-83d3-0387a8f782fd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-392-0150419039201100 mL in 1 BOTTLE (50419-392-01) 100 ml2019-07-260000-00-00NoNoCurrent