Rozlytrek (entrectinib) NDC 50242-623

NDC codes

FDA NDC Directory

Product NDC (as listed)50242-623Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50242-0623Add 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
50242-623-42	50242062342	42 DOSE PACK in 1 CARTON (50242-623-42) / 20 PELLET in 1 DOSE PACK (50242-623-01)Marketed from Oct 20, 2023

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): Rozlytrek
Generic name (nonproprietary): entrectinib
Active ingredients: Entrectinib — 50 mg/201
Dosage form: Pellet
Route: Oral
Labeler: Genentech, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 218550
Marketing start: Oct 20, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 50242-623_b93e1fc0-614a-4e49-a91d-a409fb2db9f0SPL ID b93e1fc0-614a-4e49-a91d-a409fb2db9f0SPL set ID c7c71b0c-2549-4495-86b6-c2807fa54908RxCUI 2197867, 2197873, 2197875, 2197877, 2668595, 2668599UNII L5ORF0AN1I

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

N450242062342 followed by a unit qualifier and the quantity

Package 50242-0623-42. 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 4, 2025.

Indications (excerpt from the label)

ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1.1 ) Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)