NDC 57894-421

SYLVANT

Siltuximab

SYLVANT is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Siltuximab.

Product ID57894-421_62686022-7ea4-11e8-8599-a18b9d46d017
NDC57894-421
Product TypeHuman Prescription Drug
Proprietary NameSYLVANT
Generic NameSiltuximab
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-04-01
Marketing CategoryBLA / BLA
Application NumberBLA125496
Labeler NameJanssen Biotech, Inc.
Substance NameSILTUXIMAB
Active Ingredient Strength400 mg/1
Pharm ClassesInterleukin-6 Antagonist [EPC],Interleukin-6 Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 57894-421-01

1 VIAL, SINGLE-USE in 1 CARTON (57894-421-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Marketing Start Date2014-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57894-421-01 [57894042101]

SYLVANT INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA125496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-01
Marketing End Date2021-01-31

Drug Details

Active Ingredients

IngredientStrength
SILTUXIMAB400 mg/1

OpenFDA Data

SPL SET ID:451f535b-8b6b-4ecf-9f19-d921b72eea39
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1658139
  • 1658141
  • 1658132
  • 1658135
  • Pharmacological Class

    • Interleukin-6 Antagonist [EPC]
    • Interleukin-6 Antagonists [MoA]

    NDC Crossover Matching brand name "SYLVANT" or generic name "Siltuximab"

    NDCBrand NameGeneric Name
    57894-420SYLVANTsiltuximab
    57894-421SYLVANTsiltuximab
    73090-420SylvantSiltuximab
    73090-421SylvantSiltuximab

    Trademark Results [SYLVANT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYLVANT
    SYLVANT
    86975538 4657836 Live/Registered
    JOHNSON & JOHNSON
    2013-12-12
    SYLVANT
    SYLVANT
    86142160 not registered Dead/Abandoned
    JOHNSON & JOHNSON
    2013-12-12
    SYLVANT
    SYLVANT
    77887266 not registered Dead/Abandoned
    JOHNSON & JOHNSON
    2009-12-07

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