Prescription drug · NDA
Vitrakvi (larotrectinib) NDC 50419-392
Larotrectinib 20 mg/mL · Solution, Concentrate · Oropharyngeal · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-392-01 | 50419039201 | 100 mL in 1 BOTTLE (50419-392-01)Marketed from Jul 26, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vitrakvi
- Generic name (nonproprietary)
- larotrectinib
- Active ingredients
- Larotrectinib — 20 mg/mL
- Dosage form
- Solution, Concentrate
- Route
- Oropharyngeal
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211710
- Marketing start
- Listing expires
- Other FDA classes
- Tropomyosin Receptor Kinases Inhibitors (Mechanism)
- Identifiers
- Product ID 50419-392_0e3ba6e7-af8d-4840-9409-a537a09e1263SPL ID 0e3ba6e7-af8d-4840-9409-a537a09e1263SPL set ID 0c8ca614-58b2-4aa4-83d3-0387a8f782fdRxCUI 2105633, 2105645, 2105649, 2105653, 2105655, 2105657UNII PF9462I9HX
- Pharmacologic class
- Kinase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450419039201followed by a unit qualifier and the quantityPackage 50419-0392-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Select patients for therapy based on an FDA-approved test [see Dosage and Administration (2.1) ]. VITRAKVI is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 211710
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.