Prescription drug · NDA
Vitrakvi (Larotrectinib) NDC 50419-391
Larotrectinib 100 mg/1 · Capsule · Oral · Bayer HealthCare Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50419-391-01 | 5041903910150419039101 | 60 CAPSULE in 1 BOTTLE (50419-391-01)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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210861
- Marketing start
- Listing expires
- Other FDA classes
- Tropomyosin Receptor Kinases Inhibitors (Mechanism)
- Identifiers
- Product ID 50419-391_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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450419039101followed by a unit qualifier and the quantityPackage 50419-0391-01. 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.
About NDC 50419-391
- What is NDC 50419-391?
- 50419-391 is the product NDC for Vitrakvi (larotrectinib), Larotrectinib 100 mg/1 capsule, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vitrakvi (Larotrectinib).
- What is the active ingredient?
- Larotrectinib.
- Who is the labeler?
- Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vitrakvi?
- 6 other product NDCs are listed under this name. See all Vitrakvi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vitrakvi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vitrakvilarotrectinib | Larotrectinib 20 mg/mL | Solution, ConcentrateOropharyngeal | Bayer HealthCare Pharmaceuticals Inc. | 50419-393 | 50419-0393-03 |
| Vitrakvilarotrectinib | Larotrectinib 25 mg/1 | CapsuleOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-390 | 50419-0390-01 |
| Vitrakvilarotrectinib | Larotrectinib 20 mg/mL | Solution, ConcentrateOropharyngeal | Bayer HealthCare Pharmaceuticals Inc. | 50419-392 | 50419-0392-01 |
| Vitrakvilarotrectinib | Larotrectinib 25 mg/1 | CapsuleOral | Loxo Oncology, Inc. | 71777-390 | 71777-0390-01 |
| Vitrakvilarotrectinib | Larotrectinib 100 mg/1 | CapsuleOral | Loxo Oncology, Inc. | 71777-391 | 71777-0391-01 |
| Vitrakvilarotrectinib | Larotrectinib 20 mg/mL | SolutionOral | Loxo Oncology, Inc. | 71777-392 | 71777-0392-01 |
Other NDCs under NDA 210861
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Vitrakvilarotrectinib | Larotrectinib 25 mg/1 | CapsuleOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-390 |
| Vitrakvilarotrectinib | Larotrectinib 25 mg/1 | CapsuleOral | Loxo Oncology, Inc. | 71777-390 |
| Vitrakvilarotrectinib | Larotrectinib 100 mg/1 | CapsuleOral | Loxo Oncology, Inc. | 71777-391 |