Prescription drug · NDA
Vitrakvi (Larotrectinib) NDC 71777-390
Larotrectinib 25 mg/1 · Capsule · Oral · Loxo Oncology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71777-390-01 | 7177703900171777039001 | 60 CAPSULE in 1 BOTTLE (71777-390-01)Marketed from Nov 26, 2018 |
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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Loxo Oncology, Inc.NDC labeler code 71777
- 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 71777-390_5b9e7961-f843-49d8-94b5-a2ce2c9efa46SPL ID 5b9e7961-f843-49d8-94b5-a2ce2c9efa46SPL set ID 9525f887-a055-4e33-8e92-898d42828cd1RxCUI 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
N471777039001followed by a unit qualifier and the quantityPackage 71777-0390-01. 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. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. VITRAKVI is a kinase inhibitor …
Excerpt only. Read the full label for complete information.
About NDC 71777-390
- What is NDC 71777-390?
- 71777-390 is the product NDC for Vitrakvi (larotrectinib), Larotrectinib 25 mg/1 capsule, listed with the FDA by Loxo Oncology, 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?
- Loxo Oncology, Inc., NDC labeler code 71777. 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 100 mg/1 | CapsuleOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-391 | 50419-0391-01 |
| Vitrakvilarotrectinib | Larotrectinib 20 mg/mL | Solution, ConcentrateOropharyngeal | Bayer HealthCare Pharmaceuticals Inc. | 50419-392 | 50419-0392-01 |
| 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 100 mg/1 | CapsuleOral | Bayer HealthCare Pharmaceuticals Inc. | 50419-391 |
| Vitrakvilarotrectinib | Larotrectinib 100 mg/1 | CapsuleOral | Loxo Oncology, Inc. | 71777-391 |