NDC 58406-010

ENBREL

Etanercept

ENBREL is a Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Immunex Corporation. The primary component is Etanercept.

Product ID58406-010_1bac748e-3ec9-4007-bd9a-541067a7567a
NDC58406-010
Product TypeHuman Prescription Drug
Proprietary NameENBREL
Generic NameEtanercept
Dosage FormSolution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-06-07
Marketing CategoryBLA / BLA
Application NumberBLA103795
Labeler NameImmunex Corporation
Substance NameETANERCEPT
Active Ingredient Strength25 mg/.5mL
Pharm ClassesTumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58406-010-04

4 SYRINGE in 1 CARTON (58406-010-04) > .5 mL in 1 SYRINGE (58406-010-01)
Marketing Start Date2019-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58406-010-01 [58406001001]

ENBREL SOLUTION
Marketing CategoryBLA
Application NumberBLA103795
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-07

NDC 58406-010-04 [58406001004]

ENBREL SOLUTION
Marketing CategoryBLA
Application NumberBLA103795
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-07

Drug Details

Active Ingredients

IngredientStrength
ETANERCEPT25 mg/.5mL

OpenFDA Data

SPL SET ID:a002b40c-097d-47a5-957f-7a7b1807af7f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 802652
  • 1653225
  • 809159
  • 809158
  • 261105
  • 253014
  • 1653223
  • 727757
  • Pharmacological Class

    • Tumor Necrosis Factor Blocker [EPC]
    • Tumor Necrosis Factor Receptor Blocking Activity [MoA]

    NDC Crossover Matching brand name "ENBREL" or generic name "Etanercept"

    NDCBrand NameGeneric Name
    50090-3531ENBRELetanercept
    50090-4490ENBRELetanercept
    50090-4590ENBRELetanercept
    58406-010ENBRELetanercept
    58406-021ENBRELetanercept
    58406-032ENBRELetanercept
    58406-044ENBRELetanercept
    58406-455ENBRELENBREL
    58406-456ENBRELENBREL
    58406-425ENBRELENBREL
    58406-435ENBRELENBREL
    58406-445ENBRELENBREL
    58406-446ENBRELENBREL
    58406-055ENBRELENBREL

    Trademark Results [ENBREL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ENBREL
    ENBREL
    75603024 not registered Dead/Abandoned
    Immunex Corporation
    1998-12-09
    ENBREL
    ENBREL
    75602028 2402704 Dead/Cancelled
    Immunex Corporation
    1998-12-09
    ENBREL
    ENBREL
    75602027 not registered Dead/Abandoned
    Immunex Corporation
    1998-12-09
    ENBREL
    ENBREL
    75183260 2220795 Live/Registered
    IMMUNEX CORPORATION
    1996-10-17

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