Rozlytrek
- Product NDC
- 50242-623
- 11-digit product format
- 502420623
- Labeler code
- 50242
- Product ID
- 50242-623_b93e1fc0-614a-4e49-a91d-a409fb2db9f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ENTRECTINIB
- Dosage form
- PELLET
- Route
- ORAL
- Labeler
- Genentech, Inc.
- Application
- NDA218550
- Marketing category
- NDA
- Marketing start
- 2023-10-20
- Substance
- ENTRECTINIB
- Active strength
- 50 mg/201
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| L5ORF0AN1I | ENTRECTINIB | 1108743-60-7 | ENTRECTINIB |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-623-42 | 50242062342 | 42 DOSE PACK in 1 CARTON (50242-623-42) / 20 PELLET in 1 DOSE PACK (50242-623-01) | 42 dose pack | 2023-10-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rozlytrek | Genentech, Inc. | F. Hoffmann-La Roche AG | 2025-12-04 | HUMAN PRESCRIPTION DRUG LABEL | 18 |