vitrakvi

Generic: larotrectinib

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vitrakvi
Generic Name larotrectinib
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

larotrectinib 100 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-391
Product ID 50419-391_62bb733b-5dd7-4df1-9682-c401ffa5973f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210861
Listing Expiration 2027-12-31
Marketing Start 2019-07-26

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
tropomyosin receptor kinases inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419391
Hyphenated Format 50419-391

Supplemental Identifiers

RxCUI
2105633 2105645 2105649 2105653 2105655 2105657
UNII
PF9462I9HX
NUI
N0000175605 N0000193859

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vitrakvi (source: ndc)
Generic Name larotrectinib (source: ndc)
Application Number NDA210861 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (50419-391-01)
source: ndc

Packages (1)

50419-391-01 60 CAPSULE in 1 BOTTLE (50419-391-01)

Ingredients (1)

larotrectinib (100 mg/1)

Linked Drug Pages (1)

VITRAKVI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "62bb733b-5dd7-4df1-9682-c401ffa5973f", "openfda": {"nui": ["N0000175605", "N0000193859"], "unii": ["PF9462I9HX"], "rxcui": ["2105633", "2105645", "2105649", "2105653", "2105655", "2105657"], "spl_set_id": ["0c8ca614-58b2-4aa4-83d3-0387a8f782fd"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Tropomyosin Receptor Kinases Inhibitors [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (50419-391-01)", "package_ndc": "50419-391-01", "marketing_start_date": "20190726"}], "brand_name": "VITRAKVI", "product_id": "50419-391_62bb733b-5dd7-4df1-9682-c401ffa5973f", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Tropomyosin Receptor Kinases Inhibitors [MoA]"], "product_ndc": "50419-391", "generic_name": "LAROTRECTINIB", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VITRAKVI", "active_ingredients": [{"name": "LAROTRECTINIB", "strength": "100 mg/1"}], "application_number": "NDA210861", "marketing_category": "NDA", "marketing_start_date": "20190726", "listing_expiration_date": "20271231"}