Data / Drug companies / Janssen Pharmaceuticals, Inc.
Janssen Pharmaceuticals, Inc.: 63 products in the FDA NDC directory, labeler code 50458
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Janssen Pharmaceuticals, Inc. (labeler code 50458) lists 63 products in the FDA National Drug Code Directory, covering 13 finished drugs by generic name. By type: 63 prescription drugs. Its main marketing category is new drug applications (NDA). The newest product started marketing on December 1, 2021.
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- Labeler code
- 50458
- Products in commercial distribution
- 63
- Packages
- 86
- Finished drugs by generic name
- 13
- Prescription products
- 63
- Over the counter products
- 0
- Controlled substance products
- Schedule II 4, Schedule III 1
- Flagged as original packager
- 45 of 45 products that carry the flag
- Started marketing in the last 12 months
- 0
- Products with a marketing end date set
- 3
- Earliest marketing start
- September 11, 1992
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 63 | 100% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 63 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Risperidone | 16 | 43 |
| Paliperidone palmitate | 11 | 2 |
| Canagliflozin and metformin hydrochloride | 8 | 1 |
| Rivaroxaban | 6 | 24 |
| Topiramate | 6 | 56 |
| Paliperidone | 4 | 19 |
| Methylphenidate hydrochloride | 4 | 39 |
| Canagliflozin | 2 | 3 |
| Ponesimod | 2 | 2 |
| Mebendazole | 1 | 1 |
| Pentosan polysulfate sodium | 1 | 1 |
| Esketamine hydrochloride | 1 | 1 |
| Itraconazole | 1 | 14 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 11 | 17.5% |
| Tablet, extended release | 8 | 12.7% |
| Injection, suspension, extended release | 6 | 9.5% |
| Kit | 6 | 9.5% |
| Tablet, orally disintegrating | 5 | 7.9% |
| Tablet | 5 | 7.9% |
| Injection | 5 | 7.9% |
| Tablet, coated | 4 | 6.3% |
| Tablet, film coated, extended release | 4 | 6.3% |
| Solution | 3 | 4.8% |
| Capsule, coated pellets | 2 | 3.2% |
| Tablet, chewable | 1 | 1.6% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Xarelto | 50458-575 | Granule, for suspension | New drug applications (NDA) | December 1, 2021 |
| Invega hafyera | 50458-612 | Injection, suspension, extended release | New drug applications (NDA) | August 30, 2021 |
| Invega hafyera | 50458-611 | Injection, suspension, extended release | New drug applications (NDA) | August 30, 2021 |
| Ponvory | 50458-720 | Tablet, film coated | New drug applications (NDA) | March 18, 2021 |
| Ponvory | 50458-707 | Kit | New drug applications (NDA) | March 18, 2021 |
| Spravato | 50458-028 | Solution | New drug applications (NDA) | March 5, 2019 |
| Xarelto | 50458-577 | Tablet, film coated | New drug applications (NDA) | October 9, 2018 |
| Vermox | 50458-675 | Tablet, chewable | New drug applications (NDA) | October 20, 2016 |
| Invokamet xr | 50458-943 | Tablet, film coated, extended release | New drug applications (NDA) | September 20, 2016 |
| Invokamet xr | 50458-942 | Tablet, film coated, extended release | New drug applications (NDA) | September 20, 2016 |
| Invokamet xr | 50458-941 | Tablet, film coated, extended release | New drug applications (NDA) | September 20, 2016 |
| Invokamet xr | 50458-940 | Tablet, film coated, extended release | New drug applications (NDA) | September 20, 2016 |
| Invega trinza | 50458-609 | Injection, suspension, extended release | New drug applications (NDA) | May 19, 2015 |
| Invega trinza | 50458-608 | Injection, suspension, extended release | New drug applications (NDA) | May 19, 2015 |
| Invega trinza | 50458-607 | Injection, suspension, extended release | New drug applications (NDA) | May 19, 2015 |
| Invega trinza | 50458-606 | Injection, suspension, extended release | New drug applications (NDA) | May 19, 2015 |
| Xarelto | 50458-584 | Kit | New drug applications (NDA) | September 16, 2014 |
| Invokamet | 50458-543 | Tablet, film coated | New drug applications (NDA) | August 8, 2014 |
| Invokamet | 50458-542 | Tablet, film coated | New drug applications (NDA) | August 8, 2014 |
| Invokamet | 50458-541 | Tablet, film coated | New drug applications (NDA) | August 8, 2014 |
| Invokamet | 50458-540 | Tablet, film coated | New drug applications (NDA) | August 8, 2014 |
| Invokana | 50458-141 | Tablet, film coated | New drug applications (NDA) | March 29, 2013 |
| Invokana | 50458-140 | Tablet, film coated | New drug applications (NDA) | March 29, 2013 |
| Xarelto | 50458-579 | Tablet, film coated | New drug applications (NDA) | November 5, 2011 |
| Xarelto | 50458-578 | Tablet, film coated | New drug applications (NDA) | November 4, 2011 |
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.