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 ID: 57894-640_0fd41dcd-ad17-4bb7-8c9e-cff778d75c6f
• NDC: 57894-640
• Product Type: Human Prescription Drug
• Proprietary Name: Tremfya
• Generic Name: Guselkumab
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-07-13
• Marketing Category: BLA / BLA
• Application Number: BLA761061
• Labeler Name: Janssen Biotech, Inc.
• Substance Name: GUSELKUMAB
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Interleukin-23
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 57894-640-01

1 SYRINGE in 1 CARTON (57894-640-01) > 1 mL in 1 SYRINGE

• Marketing Start Date: 2017-07-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 57894-640-99 [57894064099]

Tremfya INJECTION

• Marketing Category: BLA
• Application Number: BLA761061
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-28

NDC 57894-640-01 [57894064001]

Tremfya INJECTION

• Marketing Category: BLA
• Application Number: BLA761061
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-07-13

NDC 57894-640-11 [57894064011]

Tremfya INJECTION

• Marketing Category: BLA
• Application Number: BLA761061
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-01-28

NDC 57894-640-04 [57894064004]

Tremfya INJECTION

• Marketing Category: BLA
• Application Number: BLA761061
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-13

Drug Details

Pharmacological Class

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