Vitrakvi (larotrectinib) NDC 71777-390

NDC codes

FDA NDC Directory

Product NDC (as listed)71777-390Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71777-0390Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71777-390-01	71777039001	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.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210861
Marketing start: Nov 26, 2018
Listing expires: Dec 31, 2026
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

N471777039001 followed by a unit qualifier and the quantity

Package 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 Dec 5, 2018.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 210861

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 210861
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