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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rozlytrek
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENTRECTINIB | 50 mg/201 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L5ORF0AN1I |
| Rxcui | 2197867, 2197873, 2197875, 2197877, 2668595, 2668599 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-623-01 | Rozlytrek | 20 in 1 DOSE PACK | PELLET | 20 | | 18 |
| 50242-623-42 | Rozlytrek | 42 in 1 CARTON | PELLET | 42 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-623 | ROZLYTREK (ENTRECTINIB) CAPSULE ROZLYTREK (ENTRECTINIB) PELLET [GENENTECH, INC.] | 15 | Current NDC, 2 package rows | 20241123_c7c71b0c-2549-4495-86b6-c2807fa54908.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-623-01 | 50242062301 | 20 in 1 DOSE PACK | | | | | Historical |
| 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 | Current |