Active ingredient
Entrectinib
3 finished FDA listings contain Entrectinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ENTRECTINIB
- Dosage forms
- Capsule, Pellet
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/1 · 200 mg/1 · 50 mg/201
- Brand names in FDA listings
- Rozlytrek
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2197862
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 212725 | GENENTECH INC | 2019-08-15 | 2 |
| NDA 218550 | GENENTECH INC | 2023-10-20 | 1 |
Official labeling on DailyMed
- ROZLYTREK (ENTRECTINIB) CAPSULE ROZLYTREK (ENTRECTINIB) PELLET [GENENTECH, INC.] · version 18 · 2025-12-10
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.