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 ID50242-091_02a645ca-9221-4f0f-9182-06f02f2e07ea
NDC50242-091
Product TypeHuman Prescription Drug
Proprietary NameRozlytrek
Generic NameEntrectinib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-08-15
Marketing CategoryNDA / NDA
Application NumberNDA212725
Labeler NameGenentech, Inc.
Substance NameENTRECTINIB
Active Ingredient Strength100 mg/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50242-091-30

1 BOTTLE in 1 CARTON (50242-091-30) > 30 CAPSULE in 1 BOTTLE
Marketing Start Date2019-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-091-01 [50242009101]

Rozlytrek CAPSULE
Marketing CategoryNDA
Application NumberNDA212725
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-15
Marketing End Date2019-09-10

NDC 50242-091-30 [50242009130]

Rozlytrek CAPSULE
Marketing CategoryNDA
Application NumberNDA212725
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-15

NDC 50242-091-86 [50242009186]

Rozlytrek CAPSULE
Marketing CategoryNDA
Application NumberNDA212725
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-15

Drug Details

Active Ingredients

IngredientStrength
ENTRECTINIB100 mg/1

OpenFDA Data

SPL SET ID:c7c71b0c-2549-4495-86b6-c2807fa54908
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2197873
  • 2197877
  • 2197875
  • 2197867
  • NDC Crossover Matching brand name "Rozlytrek" or generic name "Entrectinib"

    NDCBrand NameGeneric Name
    50242-091RozlytrekENTRECTINIB
    50242-094RozlytrekENTRECTINIB

    Trademark Results [Rozlytrek]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROZLYTREK
    ROZLYTREK
    88473979 not registered Live/Pending
    Genentech, Inc.
    2019-06-14
    ROZLYTREK
    ROZLYTREK
    88302287 5910416 Live/Registered
    Genentech, Inc.
    2019-02-14

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