Data / Drug companies / Otsuka America Pharmaceutical, Inc.
Otsuka America Pharmaceutical, Inc.: 34 products in the FDA NDC directory, labeler code 59148
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Otsuka America Pharmaceutical, Inc. (labeler code 59148) lists 34 products in the FDA National Drug Code Directory, covering 6 finished drugs by generic name. By type: 34 prescription drugs. Its main marketing category is new drug applications (NDA). The newest product started marketing on October 24, 2026.
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- Labeler code
- 59148
- Products in commercial distribution
- 34
- Packages
- 54
- Finished drugs by generic name
- 6
- Prescription products
- 34
- Over the counter products
- 0
- Flagged as original packager
- 24 of 24 products that carry the flag
- Started marketing in the last 12 months
- 4
- Earliest marketing start
- November 15, 2002
- 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) | 33 | 97.1% |
| Biologics (BLA) | 1 | 2.9% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 34 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Aripiprazole | 12 | 49 |
| Tolvaptan | 9 | 9 |
| Brexpiprazole | 8 | 3 |
| Centanafadine hydrochloride | 3 | 1 |
| Dextromethorphan hydrobromide and quinidine sulfate | 1 | 4 |
| Sibeprenlimab | 1 | 1 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 16 | 47.1% |
| Kit | 11 | 32.4% |
| Capsule, extended release | 3 | 8.8% |
| Injection, suspension, extended release | 2 | 5.9% |
| Capsule, gelatin coated | 1 | 2.9% |
| Injection | 1 | 2.9% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Atypical Antipsychotic | 14 |
| Vasopressin V2 Receptor Antagonist | 4 |
| Antiarrhythmic | 1 |
| Cytochrome P450 2D6 Inhibitor | 1 |
| Sigma-1 Agonist | 1 |
| Uncompetitive N-methyl-D-aspartate Receptor Antagonist | 1 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Simtriyo | 59148-304 | Capsule, extended release | New drug applications (NDA) | October 24, 2026 |
| Simtriyo | 59148-303 | Capsule, extended release | New drug applications (NDA) | October 24, 2026 |
| Simtriyo | 59148-302 | Capsule, extended release | New drug applications (NDA) | October 24, 2026 |
| Voyxact | 59148-400 | Injection | Biologics (BLA) | November 25, 2025 |
| Abilify maintena | 59148-245 | Kit | New drug applications (NDA) | February 28, 2025 |
| Abilify maintena | 59148-232 | Kit | New drug applications (NDA) | February 28, 2025 |
| Abilify Asimtufii | 59148-114 | Injection, suspension, extended release | New drug applications (NDA) | April 27, 2023 |
| Abilify Asimtufii | 59148-102 | Injection, suspension, extended release | New drug applications (NDA) | April 27, 2023 |
| Nuedexta | 59148-053 | Capsule, gelatin coated | New drug applications (NDA) | January 3, 2023 |
| Jynarque | 59148-080 | Kit | New drug applications (NDA) | January 13, 2020 |
| Jynarque | 59148-079 | Kit | New drug applications (NDA) | January 13, 2020 |
| Jynarque | 59148-089 | Kit | New drug applications (NDA) | April 23, 2018 |
| Jynarque | 59148-088 | Kit | New drug applications (NDA) | April 23, 2018 |
| Jynarque | 59148-087 | Kit | New drug applications (NDA) | April 23, 2018 |
| Jynarque | 59148-083 | Tablet | New drug applications (NDA) | April 23, 2018 |
| Jynarque | 59148-082 | Tablet | New drug applications (NDA) | April 23, 2018 |
| Rexulti | 59148-044 | Kit | New drug applications (NDA) | July 10, 2015 |
| Rexulti | 59148-042 | Kit | New drug applications (NDA) | July 10, 2015 |
| Rexulti | 59148-040 | Tablet | New drug applications (NDA) | July 10, 2015 |
| Rexulti | 59148-039 | Tablet | New drug applications (NDA) | July 10, 2015 |
| Rexulti | 59148-038 | Tablet | New drug applications (NDA) | July 10, 2015 |
| Rexulti | 59148-037 | Tablet | New drug applications (NDA) | July 10, 2015 |
| Rexulti | 59148-036 | Tablet | New drug applications (NDA) | July 10, 2015 |
| Rexulti | 59148-035 | Tablet | New drug applications (NDA) | July 10, 2015 |
| Abilify maintena | 59148-072 | Kit | New drug applications (NDA) | October 8, 2014 |
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.