NDC 57894-060

STELARA

Ustekinumab

STELARA is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is Ustekinumab.

Product ID57894-060_17da6982-46cb-4cc7-a05b-12c3370734d1
NDC57894-060
Product TypeHuman Prescription Drug
Proprietary NameSTELARA
Generic NameUstekinumab
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2009-09-25
Marketing CategoryBLA / BLA
Application NumberBLA125261
Labeler NameJanssen Biotech, Inc.
Substance NameUSTEKINUMAB
Active Ingredient Strength45 mg/.5mL
Pharm ClassesInterleukin-12 Antagonists [MoA],Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA],Interleukin-12 Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 57894-060-02

1 VIAL, SINGLE-USE in 1 CARTON (57894-060-02) > .5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2009-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57894-060-04 [57894006004]

STELARA INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125261
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-09-25

NDC 57894-060-02 [57894006002]

STELARA INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125261
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-25

NDC 57894-060-03 [57894006003]

STELARA INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125261
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-25

Drug Details

Active Ingredients

IngredientStrength
USTEKINUMAB45 mg/.5mL

OpenFDA Data

SPL SET ID:c77a9664-e3bb-4023-b400-127aa53bca2b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1811255
  • 1811257
  • 853356
  • 853354
  • 853355
  • 853350
  • 1654083
  • 1654082
  • 1654077
  • 1654079
  • Pharmacological Class

    • Interleukin-12 Antagonists [MoA]
    • Interleukin-23 Antagonist [EPC]
    • Interleukin-23 Antagonists [MoA]
    • Interleukin-12 Antagonist [EPC]

    Medicade Reported Pricing

    57894006003 STELARA 45 MG/0.5 ML SYRINGE

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "STELARA" or generic name "Ustekinumab"

    NDCBrand NameGeneric Name
    57894-054Stelaraustekinumab
    57894-060STELARAustekinumab
    57894-061STELARAustekinumab

    Trademark Results [STELARA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STELARA
    STELARA
    78932838 3791626 Live/Registered
    Johnson & Johnson
    2006-07-19
    STELARA
    STELARA
    77725780 4049691 Live/Registered
    JOHNSON & JOHNSON
    2009-04-30

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