Data / Drug companies / Janssen Pharmaceutica NV
Janssen Pharmaceutica NV: 19 products in the FDA NDC directory, labeler code 12578
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Janssen Pharmaceutica NV (labeler code 12578) lists 19 products in the FDA National Drug Code Directory. By type: 16 bulk ingredients, 3 drugs for further processing. Its main marketing category is bulk ingredients. The newest product started marketing on March 17, 2026.
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- Labeler code
- 12578
- Products in commercial distribution
- 19
- Packages
- 22
- Finished drugs by generic name
- 0
- Prescription products
- 0
- Over the counter products
- 0
- Controlled substance products
- Schedule III 2
- Started marketing in the last 12 months
- 1
- Earliest marketing start
- February 8, 1989
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Bulk ingredients | 16 | 84.2% |
| Drugs for further processing | 3 | 15.8% |
Products by type
| Type | Products | Share |
|---|---|---|
| Bulk ingredients | 16 | 84.2% |
| Drugs for further processing | 3 | 15.8% |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Powder | 16 | 84.2% |
| Solution | 3 | 15.8% |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Icotrokinra | 12578-623 | Powder | Bulk ingredients | March 17, 2026 |
| Polyethylene glycol 400 | 12578-119 | Solution | Drugs for further processing | May 1, 2022 |
| Rilpivirine | 12578-622 | Powder | Bulk ingredients | January 21, 2021 |
| Apalutamide | 12578-621 | Powder | Bulk ingredients | February 20, 2018 |
| Mebendazole | 12578-618 | Powder | Bulk ingredients | October 19, 2016 |
| Polyethylene glycol 400 | 12578-115 | Solution | Drugs for further processing | March 15, 2016 |
| Canagliflozin | 12578-615 | Powder | Bulk ingredients | March 1, 2013 |
| Canagliflozin | 12578-611 | Powder | Bulk ingredients | March 1, 2013 |
| Miconazole nitrate | 12578-488 | Powder | Bulk ingredients | April 30, 2012 |
| Buprenorphine | 12578-607 | Powder | Bulk ingredients | May 2, 2011 |
| Abiraterone acetate | 12578-619 | Powder | Bulk ingredients | April 28, 2011 |
| Buprenorphine hydrochloride | 12578-608 | Powder | Bulk ingredients | April 11, 2011 |
| Polyethylene glycol 400 | 12578-117 | Solution | Drugs for further processing | May 1, 2008 |
| Galantamine hydrobromide | 12578-890 | Powder | Bulk ingredients | November 15, 2001 |
| Loperamide hydrochloride | 12578-409 | Powder | Bulk ingredients | March 27, 2000 |
| Cisapride | 12578-431 | Powder | Bulk ingredients | August 10, 1999 |
| Risperidone | 12578-303 | Powder | Bulk ingredients | April 23, 1999 |
| Itraconazole | 12578-299 | Powder | Bulk ingredients | May 22, 1996 |
| Haloperidol | 12578-617 | Powder | Bulk ingredients | February 8, 1989 |
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.