FDA.reportPublic FDA data

VITRAKVI

Product NDC
50419-391
11-digit product format
504190391
Labeler code
50419
Product ID
50419-391_0e3ba6e7-af8d-4840-9409-a537a09e1263
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAROTRECTINIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA210861
Marketing category
NDA
Marketing start
2019-07-26
Substance
LAROTRECTINIB
Active strength
100 mg/1
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
LAROTRECTINIB100 mg/1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-391-01VITRAKVI60 in 1 BOTTLECAPSULE6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-391-01EA - Each50419-391c571bf1e-9088-4f64-8d07-23fefb5a9fd612019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-391VITRAKVI (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
50419-391-015041903910160 CAPSULE in 1 BOTTLE (50419-391-01) 60 capsule2019-07-260000-00-00NoNoCurrent