Data / Drug companies / U.S. Pharmaceuticals
U.S. Pharmaceuticals: 22 products in the FDA NDC directory, labeler code 63539
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
U.S. Pharmaceuticals (labeler code 63539) lists 22 products in the FDA National Drug Code Directory, covering 11 finished drugs by generic name. By type: 22 prescription drugs. Its main marketing category is new drug applications (NDA). The newest product started marketing on July 9, 2024.
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- Labeler code
- 63539
- Products in commercial distribution
- 22
- Packages
- 22
- Finished drugs by generic name
- 11
- Prescription products
- 22
- Over the counter products
- 0
- Flagged as original packager
- 14 of 14 products that carry the flag
- Started marketing in the last 12 months
- 0
- Products with a marketing end date set
- 2
- Earliest marketing start
- January 27, 2012
- 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) | 21 | 95.5% |
| Biologics (BLA) | 1 | 4.5% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 22 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Tofacitinib | 5 | 23 |
| Talazoparib | 3 | 2 |
| Palbociclib | 3 | 2 |
| Abrocitinib | 3 | 2 |
| Axitinib | 2 | 2 |
| Zavegepant | 1 | 2 |
| Bosutinib | 1 | 5 |
| Ritlecitinib | 1 | 2 |
| Conjugated estrogens/bazedoxifene | 1 | 2 |
| Elranatamab-bcmm | 1 | 2 |
| Lorlatinib | 1 | 2 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 13 | 59.1% |
| Capsule, liquid filled | 2 | 9.1% |
| Capsule | 2 | 9.1% |
| Tablet, extended release | 2 | 9.1% |
| Spray | 1 | 4.5% |
| Injection, solution | 1 | 4.5% |
| Solution | 1 | 4.5% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Kinase Inhibitor | 8 |
| Janus Kinase Inhibitor | 8 |
| Poly(ADP-Ribose) Polymerase Inhibitor | 3 |
| Calcitonin Gene-related Peptide Receptor Antagonist | 1 |
| Estrogen | 1 |
| Estrogen Agonist/Antagonist | 1 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Talzenna | 63539-031 | Capsule, liquid filled | New drug applications (NDA) | July 9, 2024 |
| Talzenna | 63539-025 | Capsule, liquid filled | New drug applications (NDA) | July 9, 2024 |
| Elrexfio | 63539-252 | Injection, solution | Biologics (BLA) | August 15, 2023 |
| Litfulo | 63539-334 | Capsule | New drug applications (NDA) | July 6, 2023 |
| Zavzpret | 63539-135 | Spray | New drug applications (NDA) | June 1, 2023 |
| Lorbrena | 63539-927 | Tablet, film coated | New drug applications (NDA) | January 3, 2023 |
| Cibinqo | 63539-436 | Tablet, film coated | New drug applications (NDA) | February 24, 2022 |
| Cibinqo | 63539-336 | Tablet, film coated | New drug applications (NDA) | February 24, 2022 |
| Cibinqo | 63539-236 | Tablet, film coated | New drug applications (NDA) | February 24, 2022 |
| Xeljanz | 63539-029 | Solution | New drug applications (NDA) | February 8, 2021 |
| Ibrance | 63539-688 | Tablet, film coated | New drug applications (NDA) | March 30, 2020 |
| Ibrance | 63539-486 | Tablet, film coated | New drug applications (NDA) | March 30, 2020 |
| Ibrance | 63539-284 | Tablet, film coated | New drug applications (NDA) | March 30, 2020 |
| Xeljanz xr | 63539-502 | Tablet, extended release | New drug applications (NDA) | January 21, 2020 |
| Talzenna | 63539-295 | Capsule | New drug applications (NDA) | December 10, 2018 |
| Xeljanz | 63539-016 | Tablet, film coated | New drug applications (NDA) | July 2, 2018 |
| Xeljanz xr | 63539-501 | Tablet, extended release | New drug applications (NDA) | March 7, 2016 |
| Duavee | 63539-122 | Tablet, film coated | New drug applications (NDA) | November 15, 2013 |
| Xeljanz | 63539-012 | Tablet, film coated | New drug applications (NDA) | November 8, 2012 |
| Bosulif | 63539-193 | Tablet, film coated | New drug applications (NDA) | September 4, 2012 |
| Inlyta | 63539-044 | Tablet, film coated | New drug applications (NDA) | January 27, 2012 |
| Inlyta | 63539-026 | Tablet, film coated | New drug applications (NDA) | January 27, 2012 |
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.