Rozlytrek (entrectinib) NDC 50242-094

NDC codes

FDA NDC Directory

Product NDC (as listed)50242-094Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50242-0094Add 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
50242-094-47	50242009447	1 BOTTLE in 1 CARTON (50242-094-47) / 90 CAPSULE in 1 BOTTLEMarketed from Aug 15, 2019 · Sample package
50242-094-90	50242009490	1 BOTTLE in 1 CARTON (50242-094-90) / 90 CAPSULE in 1 BOTTLEMarketed from Aug 15, 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): Rozlytrek
Generic name (nonproprietary): entrectinib
Active ingredients: Entrectinib — 200 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Genentech, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 212725
Marketing start: Aug 15, 2019
Listing expires: Dec 31, 2026
Identifiers: Product ID 50242-094_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

N450242009447 followed by a unit qualifier and the quantity

Package 50242-0094-47. 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)

Other NDCs under NDA 212725

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

FDA NDC Directory listings under NDA 212725
Product	Strength	Form · route	Labeler	Product NDC
Rozlytrekentrectinib	Entrectinib 100 mg/1	CapsuleOral	Genentech, Inc.	50242-091