rozlytrek

Generic: entrectinib

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rozlytrek
Generic Name entrectinib
Labeler genentech, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

entrectinib 100 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-091
Product ID 50242-091_b93e1fc0-614a-4e49-a91d-a409fb2db9f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212725
Listing Expiration 2026-12-31
Marketing Start 2019-08-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242091
Hyphenated Format 50242-091

Supplemental Identifiers

RxCUI
2197867 2197873 2197875 2197877 2668595 2668599
UNII
L5ORF0AN1I

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rozlytrek (source: ndc)
Generic Name entrectinib (source: ndc)
Application Number NDA212725 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50242-091-30) / 30 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50242-091-86) / 30 CAPSULE in 1 BOTTLE
source: ndc

Packages (2)

50242-091-30 1 BOTTLE in 1 CARTON (50242-091-30) / 30 CAPSULE in 1 BOTTLE 50242-091-86 1 BOTTLE in 1 CARTON (50242-091-86) / 30 CAPSULE in 1 BOTTLE

Ingredients (1)

entrectinib (100 mg/1)

Linked Drug Pages (1)

Rozlytrek ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b93e1fc0-614a-4e49-a91d-a409fb2db9f0", "openfda": {"unii": ["L5ORF0AN1I"], "rxcui": ["2197867", "2197873", "2197875", "2197877", "2668595", "2668599"], "spl_set_id": ["c7c71b0c-2549-4495-86b6-c2807fa54908"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50242-091-30)  / 30 CAPSULE in 1 BOTTLE", "package_ndc": "50242-091-30", "marketing_start_date": "20190815"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (50242-091-86)  / 30 CAPSULE in 1 BOTTLE", "package_ndc": "50242-091-86", "marketing_start_date": "20190815"}], "brand_name": "Rozlytrek", "product_id": "50242-091_b93e1fc0-614a-4e49-a91d-a409fb2db9f0", "dosage_form": "CAPSULE", "product_ndc": "50242-091", "generic_name": "ENTRECTINIB", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rozlytrek", "active_ingredients": [{"name": "ENTRECTINIB", "strength": "100 mg/1"}], "application_number": "NDA212725", "marketing_category": "NDA", "marketing_start_date": "20190815", "listing_expiration_date": "20261231"}