Data / Drug companies / Lubiprostone
Lubiprostone: 20 companies and 43 products in the FDA NDC directory
Lubiprostone is listed in the FDA National Drug Code Directory by 20 companies, with 43 products in commercial distribution. 18 of the products (41.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, gelatin coated; capsule, and the newest product started marketing on March 18, 2026.
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- Companies listing it
- 20
- Products
- 43
- Generic (ANDA) products
- 18 (41.9%)
- Application numbers
- 5
- Routes
- Oral
- Brand names
- Amitiza, Amitza
- openFDA record search
- api.fda.gov
Companies that list lubiprostone
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Asclemed USA, Inc. | 4 | capsule; capsule, gelatin coated | Generic drugs (ANDA) | March 23, 2023 |
| Proficient Rx LP | 3 | capsule, gelatin coated | Authorized generics (NDA) | January 1, 2023 |
| Advanced Rx of Tennessee, LLC | 2 | capsule, gelatin coated | Authorized generics (NDA) | August 16, 2023 |
| American Health Packaging | 2 | capsule, gelatin coated | Generic drugs (ANDA) | March 18, 2026 |
| Amneal Pharmaceuticals LLC | 2 | capsule | Generic drugs (ANDA) | December 3, 2021 |
| Camber Pharmaceuticals, Inc. | 2 | capsule | Generic drugs (ANDA) | May 27, 2025 |
| Direct_Rx | 2 | capsule, gelatin coated | Generic drugs (ANDA) | January 16, 2025 |
| Dr. Reddy's Laboratories Inc. | 2 | capsule, gelatin coated | Authorized generics (NDA) | January 1, 2023 |
| Golden State Medical Supply, Inc. | 2 | capsule, gelatin coated | Authorized generics (NDA) | April 29, 2008 |
| Natco Pharma USA LLC | 2 | capsule, gelatin coated | Authorized generics (NDA) | October 17, 2022 |
| NorthStar RxLLC | 2 | capsule | Generic drugs (ANDA) | July 1, 2025 |
| Par Health USA, LLC | 2 | capsule, gelatin coated | Authorized generics (NDA) | January 1, 2021 |
| Proficient Rx LP | 2 | capsule, gelatin coated | Authorized generics (NDA) | January 3, 2023 |
| SpecGx LLC | 2 | capsule, gelatin coated | New drug applications (NDA) | April 1, 2024 |
| SpecGx LLC | 2 | capsule, gelatin coated | Authorized generics (NDA) | May 1, 2024 |
| Sun Pharmaceutical Industries, Inc. | 2 | capsule, gelatin coated | Authorized generics (NDA) | January 1, 2023 |
| Takeda Pharmaceuticals America, Inc. | 2 | capsule, gelatin coated | New drug applications (NDA) | January 31, 2006 |
| Teva Pharmaceuticals, Inc. | 2 | capsule, gelatin coated | Generic drugs (ANDA) | January 3, 2023 |
| Zydus Lifesciences Limited | 2 | capsule | Generic drugs (ANDA) | March 23, 2023 |
| Zydus Pharmaceuticals USA Inc. | 2 | capsule | Generic drugs (ANDA) | March 23, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule, gelatin coated | 31 | 72.1% |
| Capsule | 12 | 27.9% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Authorized generics (NDA) | 21 | 48.8% |
| Generic drugs (ANDA) | 18 | 41.9% |
| New drug applications (NDA) | 4 | 9.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Chloride Channel Activator | 43 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). 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.