Data / Drug companies / Janssen Biotech, Inc.
Janssen Biotech, Inc.: 37 products in the FDA NDC directory, labeler code 57894
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Janssen Biotech, Inc. (labeler code 57894) lists 37 products in the FDA National Drug Code Directory, covering 17 finished drugs by generic name. By type: 36 prescription drugs, 1 cellular therapies. Its main marketing category is biologics (BLA). The newest product started marketing on March 17, 2026.
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- Labeler code
- 57894
- Products in commercial distribution
- 37
- Packages
- 62
- Finished drugs by generic name
- 17
- Prescription products
- 36
- Over the counter products
- 0
- Flagged as original packager
- 19 of 19 products that carry the flag
- Started marketing in the last 12 months
- 5
- Earliest marketing start
- August 24, 1998
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Biologics (BLA) | 29 | 78.4% |
| New drug applications (NDA) | 8 | 21.6% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 36 | 97.3% |
| Cellular therapies | 1 | 2.7% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Ustekinumab | 6 | 2 |
| Amivantamab and hyaluronidase-lpuj (human recombinant) | 4 | 1 |
| Golimumab | 3 | 1 |
| Guselkumab | 3 | 1 |
| Lazertinib | 2 | 1 |
| Daratumumab | 2 | 1 |
| Abiraterone acetate | 2 | 22 |
| Talquetamab-tgvs | 2 | 1 |
| Niraparib tosylate monohydrate and abiraterone acetate | 2 | 1 |
| Teclistamab-cqyv | 2 | 1 |
| Nipocalimab-aahu | 2 | 1 |
| Infliximab | 2 | 2 |
| Gemcitabine intravesical | 1 | 1 |
| Daratumumab and hyaluronidase-fihj (human recombinant) | 1 | 1 |
| Ciltacabtagene autoleucel | 1 | 1 |
| Icotrokinra | 1 | 1 |
| Amivantamab-vmjw | 1 | 1 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 13 | 35.1% |
| Injection, solution | 6 | 16.2% |
| Tablet, film coated | 6 | 16.2% |
| Injection, solution, concentrate | 4 | 10.8% |
| Solution | 3 | 8.1% |
| Injection, powder, lyophilized, for solution | 2 | 5.4% |
| Tablet | 1 | 2.7% |
| System | 1 | 2.7% |
| Injection, suspension | 1 | 2.7% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Interleukin-23 Antagonist | 9 |
| Interleukin-12 Antagonist | 6 |
| Tumor Necrosis Factor Blocker | 5 |
| Endoglycosidase | 5 |
| Cytochrome P450 17A1 Inhibitor | 4 |
| CD38-directed Cytolytic Antibody | 3 |
| Kinase Inhibitor | 2 |
| Poly(ADP-Ribose) Polymerase Inhibitor | 2 |
| Nucleoside Metabolic Inhibitor | 1 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Icotyde | 57894-201 | Tablet, film coated | New drug applications (NDA) | March 17, 2026 |
| Rybrevant Faspro | 57894-522 | Injection | Biologics (BLA) | February 13, 2026 |
| Rybrevant Faspro | 57894-515 | Injection | Biologics (BLA) | February 13, 2026 |
| Rybrevant Faspro | 57894-514 | Injection | Biologics (BLA) | December 19, 2025 |
| Rybrevant Faspro | 57894-510 | Injection | Biologics (BLA) | December 19, 2025 |
| Inlexzo | 57894-225 | System | New drug applications (NDA) | September 14, 2025 |
| Imaavy | 57894-801 | Injection, solution, concentrate | Biologics (BLA) | April 29, 2025 |
| Imaavy | 57894-800 | Injection, solution, concentrate | Biologics (BLA) | April 29, 2025 |
| Ustekinumab | 57894-444 | Solution | Biologics (BLA) | April 1, 2025 |
| Ustekinumab | 57894-441 | Injection, solution | Biologics (BLA) | April 1, 2025 |
| Ustekinumab | 57894-440 | Injection, solution | Biologics (BLA) | April 1, 2025 |
| Tremfya | 57894-651 | Injection | Biologics (BLA) | September 11, 2024 |
| Tremfya | 57894-650 | Injection | Biologics (BLA) | September 11, 2024 |
| Lazcluze | 57894-240 | Tablet, film coated | New drug applications (NDA) | August 20, 2024 |
| Lazcluze | 57894-080 | Tablet, film coated | New drug applications (NDA) | August 20, 2024 |
| Akeega | 57894-100 | Tablet, film coated | New drug applications (NDA) | August 11, 2023 |
| Akeega | 57894-050 | Tablet, film coated | New drug applications (NDA) | August 11, 2023 |
| Talvey | 57894-470 | Injection | Biologics (BLA) | August 9, 2023 |
| Talvey | 57894-469 | Injection | Biologics (BLA) | August 9, 2023 |
| Tecvayli | 57894-450 | Injection | Biologics (BLA) | October 25, 2022 |
| Tecvayli | 57894-449 | Injection | Biologics (BLA) | October 25, 2022 |
| Carvykti | 57894-111 | Injection, suspension | Biologics (BLA) | February 28, 2022 |
| Darzalex IV | 57894-505 | Injection, solution, concentrate | Biologics (BLA) | October 15, 2021 |
| Infliximab | 57894-160 | Injection, powder, lyophilized, for solution | Biologics (BLA) | October 5, 2021 |
| Rybrevant | 57894-501 | Injection | Biologics (BLA) | May 21, 2021 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.