NDC 64116-121

Esbriet

Pirfenidone

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

Product ID64116-121_58cc9885-2828-435d-9db2-8e94cdecfa00
NDC64116-121
Product TypeHuman Prescription Drug
Proprietary NameEsbriet
Generic NamePirfenidone
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2014-10-16
Marketing CategoryNDA / NDA
Application NumberNDA022535
Labeler NameInterMune, Inc.
Substance NamePIRFENIDONE
Active Ingredient Strength267 mg/1
Pharm ClassesPyridone [EPC],Pyridones [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 64116-121-01

1 BOTTLE, PLASTIC in 1 CARTON (64116-121-01) > 270 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date2014-10-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64116-121-02 [64116012102]

Esbriet CAPSULE
Marketing CategoryNDA
Application NumberNDA022535
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-16
Inactivation Date2020-01-31

NDC 64116-121-01 [64116012101]

Esbriet CAPSULE
Marketing CategoryNDA
Application NumberNDA022535
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-16
Inactivation Date2020-01-31

NDC 64116-121-03 [64116012103]

Esbriet CAPSULE
Marketing CategoryNDA
Application NumberNDA022535
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PIRFENIDONE267 mg/1

OpenFDA Data

SPL SET ID:0ab861c2-d5ca-4f92-854c-6477971a1b38
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1592285
  • 1592279

    • 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
    64116-121EsbrietEsbriet
    0480-3610PirfenidonePirfenidone
    0480-3611PirfenidonePirfenidone
    0781-2158PirfenidonePirfenidone
    0781-8085PirfenidonePirfenidone
    0781-8086PirfenidonePirfenidone
    16729-467PIRFENIDONEPIRFENIDONE
    16729-468PIRFENIDONEPIRFENIDONE
    31722-872PirfenidonePirfenidone
    31722-873PirfenidonePirfenidone
    42385-923PirfenidonePirfenidone
    42385-924PirfenidonePirfenidone
    42385-925PirfenidonePirfenidone
    42385-926PirfenidonePirfenidone
    42571-335PirfenidonePirfenidone
    42571-336PirfenidonePirfenidone
    50228-441PIRFENIDONEPIRFENIDONE
    50228-442PIRFENIDONEPIRFENIDONE
    50228-443PIRFENIDONEPIRFENIDONE
    60219-1640PirfenidonePirfenidone
    60219-1641PirfenidonePirfenidone
    60219-1642PirfenidonePirfenidone
    62332-479PirfenidonePirfenidone

    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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