NDC 50090-3531

ENBREL

Etanercept

ENBREL is a Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Etanercept.

Product ID50090-3531_195ae3ec-be75-4913-9298-0f129e8855d0
NDC50090-3531
Product TypeHuman Prescription Drug
Proprietary NameENBREL
Generic NameEtanercept
Dosage FormSolution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2005-11-10
Marketing CategoryBLA / BLA
Application NumberBLA103795
Labeler NameA-S Medication Solutions
Substance NameETANERCEPT
Active Ingredient Strength50 mg/mL
Pharm ClassesTumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50090-3531-0

1 mL in 1 KIT (50090-3531-0)
Marketing Start Date2018-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-3531-0 [50090353100]

ENBREL SOLUTION
Marketing CategoryBLA
Application NumberBLA103795
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ETANERCEPT50 mg/mL

OpenFDA Data

SPL SET ID:74bead6e-b746-4134-817f-0c053ef9e451
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1653223
  • 1653225

    • 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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