TREMFYA
- Product NDC
- 57894-650
- 11-digit product format
- 578940650
- Labeler code
- 57894
- Product ID
- 57894-650_ebe07a22-1b8b-4403-99dc-e7f34308d5d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Guselkumab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA761061
- Marketing category
- BLA
- Marketing start
- 2024-09-11
- Substance
- GUSELKUMAB
- Active strength
- 200 mg/20mL
- Pharmacologic classes
- Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 089658A12D | GUSELKUMAB | 1350289-85-8 | GUSELKUMAB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 57894-650-02 | 57894065002 | 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-650-02) / 20 mL in 1 VIAL, SINGLE-DOSE (57894-650-01) | 2024-09-11 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| TREMFYA | Janssen Biotech, Inc. | AndersonBrecon Inc. | Janssen Pharmaceutica, NV | Jannsen Biologics B.V. | Cilag AG | Biogen MA, Inc. | PPD Development Ireland Ltd. | Janssen Sciences Ireland UC | 2025-09-29 | HUMAN PRESCRIPTION DRUG LABEL | 28 |
| TREMFYA | Janssen Biotech, Inc. | AndersonBrecon Inc. | Janssen Pharmaceutica NV | Janssen Biologics B.V. | Cilag AG | Biogen MA Inc. | PPD Development Ireland Ltd. | Janssen Sciences Ireland UC | 2025-09-29 | HUMAN PRESCRIPTION DRUG LABEL | 25 |