Data / Drug companies / Takeda Pharmaceuticals America, Inc.
Takeda Pharmaceuticals America, Inc.: 32 products in the FDA NDC directory, labeler code 54092
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Takeda Pharmaceuticals America, Inc. (labeler code 54092) lists 32 products in the FDA National Drug Code Directory, covering 9 finished drugs by generic name. By type: 32 prescription drugs. Its main marketing category is new drug applications (NDA). The newest product started marketing on December 14, 2018.
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- Labeler code
- 54092
- Products in commercial distribution
- 32
- Packages
- 37
- Finished drugs by generic name
- 9
- Prescription products
- 32
- Over the counter products
- 0
- Controlled substance products
- Schedule II 10
- Flagged as original packager
- 28 of 28 products that carry the flag
- Started marketing in the last 12 months
- 0
- Earliest marketing start
- May 10, 1993
- 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) | 29 | 90.6% |
| Biologics (BLA) | 2 | 6.2% |
| Authorized generics (NDA) | 1 | 3.1% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 32 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Lanthanum carbonate | 5 | 7 |
| Mesalamine | 4 | 41 |
| Guanfacine | 4 | 33 |
| Carbamazepine | 3 | 52 |
| Prucalopride | 2 | 18 |
| Idursulfase | 1 | 1 |
| Velaglucerase alfa | 1 | 1 |
| Icatibant acetate | 1 | 1 |
| Anagrelide hydrochloride | 1 | 1 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule, extended release | 13 | 40.6% |
| Tablet, extended release | 4 | 12.5% |
| Tablet, chewable | 3 | 9.4% |
| Capsule | 3 | 9.4% |
| Tablet, delayed release | 2 | 6.2% |
| Tablet, film coated | 2 | 6.2% |
| Powder | 2 | 6.2% |
| Solution, concentrate | 1 | 3.1% |
| Injection, powder, lyophilized, for solution | 1 | 3.1% |
| Injection, solution | 1 | 3.1% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Motegrity | 54092-547 | Tablet, film coated | New drug applications (NDA) | December 14, 2018 |
| Motegrity | 54092-546 | Tablet, film coated | New drug applications (NDA) | December 14, 2018 |
| Mesalamine | 54092-100 | Tablet, delayed release | Authorized generics (NDA) | August 29, 2017 |
| Mydayis | 54092-477 | Capsule, extended release | New drug applications (NDA) | June 20, 2017 |
| Mydayis | 54092-474 | Capsule, extended release | New drug applications (NDA) | June 20, 2017 |
| Mydayis | 54092-471 | Capsule, extended release | New drug applications (NDA) | June 20, 2017 |
| Mydayis | 54092-468 | Capsule, extended release | New drug applications (NDA) | June 20, 2017 |
| Fosrenol | 54092-257 | Powder | New drug applications (NDA) | September 24, 2014 |
| Fosrenol | 54092-256 | Powder | New drug applications (NDA) | September 24, 2014 |
| Firazyr | 54092-702 | Injection, solution | New drug applications (NDA) | August 25, 2011 |
| Vpriv | 54092-701 | Injection, powder, lyophilized, for solution | Biologics (BLA) | February 26, 2010 |
| Intuniv | 54092-519 | Tablet, extended release | New drug applications (NDA) | September 2, 2009 |
| Intuniv | 54092-517 | Tablet, extended release | New drug applications (NDA) | September 2, 2009 |
| Intuniv | 54092-515 | Tablet, extended release | New drug applications (NDA) | September 2, 2009 |
| Intuniv | 54092-513 | Tablet, extended release | New drug applications (NDA) | September 2, 2009 |
| Lialda | 54092-476 | Tablet, delayed release | New drug applications (NDA) | January 16, 2007 |
| Elaprase | 54092-700 | Solution, concentrate | Biologics (BLA) | July 24, 2006 |
| Fosrenol | 54092-254 | Tablet, chewable | New drug applications (NDA) | November 23, 2005 |
| Fosrenol | 54092-253 | Tablet, chewable | New drug applications (NDA) | November 23, 2005 |
| Fosrenol | 54092-252 | Tablet, chewable | New drug applications (NDA) | October 26, 2004 |
| Pentasa | 54092-191 | Capsule | New drug applications (NDA) | July 8, 2004 |
| Adderall XR | 54092-389 | Capsule, extended release | New drug applications (NDA) | May 22, 2002 |
| Adderall XR | 54092-385 | Capsule, extended release | New drug applications (NDA) | May 22, 2002 |
| Adderall XR | 54092-381 | Capsule, extended release | New drug applications (NDA) | May 22, 2002 |
| Adderall XR | 54092-391 | Capsule, extended release | New drug applications (NDA) | October 11, 2001 |
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.