NDC 50242-091

Rozlytrek

Entrectinib

Rozlytrek is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Entrectinib.

• Product ID: 50242-091_02a645ca-9221-4f0f-9182-06f02f2e07ea
• NDC: 50242-091
• Product Type: Human Prescription Drug
• Proprietary Name: Rozlytrek
• Generic Name: Entrectinib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-15
• Marketing Category: NDA / NDA
• Application Number: NDA212725
• Labeler Name: Genentech, Inc.
• Substance Name: ENTRECTINIB
• Active Ingredient Strength: 100 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50242-091-30

1 BOTTLE in 1 CARTON (50242-091-30) > 30 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2019-08-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-091-01 [50242009101]

Rozlytrek CAPSULE

• Marketing Category: NDA
• Application Number: NDA212725
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-15
• Marketing End Date: 2019-09-10

NDC 50242-091-30 [50242009130]

Rozlytrek CAPSULE

• Marketing Category: NDA
• Application Number: NDA212725
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-15

NDC 50242-091-86 [50242009186]

Rozlytrek CAPSULE

• Marketing Category: NDA
• Application Number: NDA212725
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-08-15

Drug Details

Active Ingredients

Ingredient	Strength
ENTRECTINIB	100 mg/1

OpenFDA Data

• SPL SET ID: c7c71b0c-2549-4495-86b6-c2807fa54908
• Manufacturer:
  • Genentech Inc.
• UNII:
  • L5ORF0AN1I
• RxNorm Concept Unique ID - RxCUI:
  • 2197873
  • 2197877
  • 2197875
  • 2197867

NDC Crossover Matching brand name "Rozlytrek" or generic name "Entrectinib"

NDC	Brand Name	Generic Name
50242-091	Rozlytrek	ENTRECTINIB
50242-094	Rozlytrek	ENTRECTINIB