NDC 57894-640

Tremfya

Guselkumab

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

Product ID57894-640_0fd41dcd-ad17-4bb7-8c9e-cff778d75c6f
NDC57894-640
Product TypeHuman Prescription Drug
Proprietary NameTremfya
Generic NameGuselkumab
Dosage FormInjection
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2017-07-13
Marketing CategoryBLA / BLA
Application NumberBLA761061
Labeler NameJanssen Biotech, Inc.
Substance NameGUSELKUMAB
Active Ingredient Strength100 mg/mL
Pharm ClassesInterleukin-23
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 57894-640-01

1 SYRINGE in 1 CARTON (57894-640-01) > 1 mL in 1 SYRINGE
Marketing Start Date2017-07-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57894-640-99 [57894064099]

Tremfya INJECTION
Marketing CategoryBLA
Application NumberBLA761061
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-28

NDC 57894-640-01 [57894064001]

Tremfya INJECTION
Marketing CategoryBLA
Application NumberBLA761061
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-13

NDC 57894-640-11 [57894064011]

Tremfya INJECTION
Marketing CategoryBLA
Application NumberBLA761061
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-01-28

NDC 57894-640-04 [57894064004]

Tremfya INJECTION
Marketing CategoryBLA
Application NumberBLA761061
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-13

Drug Details

Pharmacological Class

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

Trademark Results [Tremfya]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TREMFYA
TREMFYA
86799255 5297001 Live/Registered
JOHNSON & JOHNSON
2015-10-26

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