FDA.reportPublic FDA data

VITRAKVI

Product NDC
71777-391
11-digit product format
717770391
Labeler code
71777
Product ID
71777-391_5b9e7961-f843-49d8-94b5-a2ce2c9efa46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAROTRECTINIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Loxo Oncology, Inc.
Application
NDA210861
Marketing category
NDA
Marketing start
2018-11-26
Substance
LAROTRECTINIB
Active strength
100 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VITRAKVI
Listing expiration
2026-12-31

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
0fc8d6a0-e17e-438b-8b82-328781db0b4cProduct name220190320

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71777-391-01VITRAKVI60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71777-391-01EA - Each71777-391824c66c2-9244-4675-bead-f8149b59994912018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71777-391VITRAKVI (LAROTRECTINIB) CAPSULE VITRAKVI (LAROTRECTINIB) SOLUTION [LOXO ONCOLOGY, INC.]3Current NDC, Legacy NDC, 1 package rows20190502_9525f887-a055-4e33-8e92-898d42828cd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2105633larotrectinib 100 MG Oral CapsulePSN9525f887-a055-4e33-8e92-898d42828cd13
2105649larotrectinib 20 MG in 1 mL Oral SolutionPSN9525f887-a055-4e33-8e92-898d42828cd13
2105655larotrectinib 25 MG Oral CapsulePSN9525f887-a055-4e33-8e92-898d42828cd13
2105645VITRAKVI 100 MG Oral CapsulePSN9525f887-a055-4e33-8e92-898d42828cd13
2105653VITRAKVI 20 MG in 1 mL Oral SolutionPSN9525f887-a055-4e33-8e92-898d42828cd13
2105657VITRAKVI 25 MG Oral CapsulePSN9525f887-a055-4e33-8e92-898d42828cd13
2105645larotrectinib 100 MG Oral Capsule [Vitrakvi]SBD9525f887-a055-4e33-8e92-898d42828cd13
2105653larotrectinib 20 MG/ML Oral Solution [Vitrakvi]SBD9525f887-a055-4e33-8e92-898d42828cd13
2105657larotrectinib 25 MG Oral Capsule [Vitrakvi]SBD9525f887-a055-4e33-8e92-898d42828cd13
2105633larotrectinib 100 MG Oral CapsuleSCD9525f887-a055-4e33-8e92-898d42828cd13
2105649larotrectinib 20 MG/ML Oral SolutionSCD9525f887-a055-4e33-8e92-898d42828cd13
2105655larotrectinib 25 MG Oral CapsuleSCD9525f887-a055-4e33-8e92-898d42828cd13
2105633larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsuleSY9525f887-a055-4e33-8e92-898d42828cd13
2105649larotrectinib 20 MG (as 24.6 MG larotrectinib sulfate) per 1 ML Oral SolutionSY9525f887-a055-4e33-8e92-898d42828cd13
2105649larotrectinib 20 MG per 1 ML Oral SolutionSY9525f887-a055-4e33-8e92-898d42828cd13
2105655larotrectinib 25 MG (as 30.7 MG larotrectinib sulfate) Oral CapsuleSY9525f887-a055-4e33-8e92-898d42828cd13
2105645Vitrakvi 100 MG (as 123 MG larotrectinib sulfate) Oral CapsuleSY9525f887-a055-4e33-8e92-898d42828cd13
2105645Vitrakvi 100 MG Oral CapsuleSY9525f887-a055-4e33-8e92-898d42828cd13
2105653Vitrakvi 20 MG (as 24.6 MG larotrectinib sulfate) per 1 mL Oral SolutionSY9525f887-a055-4e33-8e92-898d42828cd13
2105653Vitrakvi 20 MG per 1 mL Oral SolutionSY9525f887-a055-4e33-8e92-898d42828cd13
2105653Vitrakvi 20 MG/ML Oral SolutionSY9525f887-a055-4e33-8e92-898d42828cd13
2105657Vitrakvi 25 MG (as 30.7 MG larotrectinib sulfate) Oral CapsuleSY9525f887-a055-4e33-8e92-898d42828cd13
2105657Vitrakvi 25 MG Oral CapsuleSY9525f887-a055-4e33-8e92-898d42828cd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71777-391-017177703910160 CAPSULE in 1 BOTTLE (71777-391-01) 60 capsule2018-11-260000-00-00NoNoCurrent