NDC 50242-121

ESBRIET

Pirfenidone

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

Product ID50242-121_037b768f-6ad3-4167-a2ef-c9784c36599f
NDC50242-121
Product TypeHuman Prescription Drug
Proprietary NameESBRIET
Generic NamePirfenidone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2014-10-15
Marketing CategoryNDA / NDA
Application NumberNDA022535
Labeler NameGenentech, Inc.
Substance NamePIRFENIDONE
Active Ingredient Strength267 mg/1
Pharm ClassesPyridone [EPC],Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50242-121-01

1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) > 270 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date2014-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50242-121-87 [50242012187]

ESBRIET CAPSULE
Marketing CategoryNDA
Application NumberNDA022535
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-11-28
Marketing End Date2020-01-31

NDC 50242-121-02 [50242012102]

ESBRIET CAPSULE
Marketing CategoryNDA
Application NumberNDA022535
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-16
Marketing End Date2017-11-15

NDC 50242-121-03 [50242012103]

ESBRIET CAPSULE
Marketing CategoryNDA
Application NumberNDA022535
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-16
Marketing End Date2017-11-15

NDC 50242-121-01 [50242012101]

ESBRIET CAPSULE
Marketing CategoryNDA
Application NumberNDA022535
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-15

Drug Details

Active Ingredients

IngredientStrength
PIRFENIDONE267 mg/1

OpenFDA Data

SPL SET ID:2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1868020
  • 1868018
  • 1592285
  • 1592279
  • 1868016
  • 1868014
  • Pharmacological Class

    • Pyridone [EPC]
    • Pyridones [CS]

    NDC Crossover Matching brand name "ESBRIET" or generic name "Pirfenidone"

    NDCBrand NameGeneric Name
    50242-121ESBRIETPIRFENIDONE
    50242-122ESBRIETPIRFENIDONE
    50242-123ESBRIETPIRFENIDONE
    64116-121Esbrietpirfenidone
    0480-3610PirfenidonePirfenidone
    0480-3611PirfenidonePirfenidone
    0781-8085PirfenidonePirfenidone
    0781-8086PirfenidonePirfenidone
    60219-1640PirfenidonePirfenidone
    60219-1641PirfenidonePirfenidone
    60219-1642PirfenidonePirfenidone

    Trademark Results [ESBRIET]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ESBRIET
    ESBRIET
    86332703 4688507 Live/Registered
    GENENTECH, INC.
    2014-07-09
    ESBRIET
    ESBRIET
    77527761 4132175 Live/Registered
    GENENTECH, INC.
    2008-07-21

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