TREMFYA
- Product NDC
- 57894-651
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- guselkumab
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA761061
- Marketing category
- BLA
- Substance
- GUSELKUMAB
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 57894-651-02 | 1 SYRINGE in 1 CARTON (57894-651-02) / 2 mL in 1 SYRINGE (57894-651-01) | 2024-09-11 | | No | Historical |
| 57894-651-04 | 2 CARTON in 1 CARTON (57894-651-04) / 1 SYRINGE in 1 CARTON (57894-651-02) / 2 mL in 1 SYRINGE (57894-651-01) | 2025-03-20 | | No | Historical |
| 57894-651-22 | 1 SYRINGE in 1 CARTON (57894-651-22) / 2 mL in 1 SYRINGE (57894-651-11) | 2024-09-11 | | No | Historical |
| 57894-651-92 | 1 SYRINGE in 1 CARTON (57894-651-92) / 2 mL in 1 SYRINGE (57894-651-99) | 2024-09-11 | | 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 |