Data / Drug companies / Lactulose
Lactulose: 18 companies and 33 products in the FDA NDC directory
Lactulose is listed in the FDA National Drug Code Directory by 18 companies, with 33 products in commercial distribution. 33 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are solution; powder, for solution, and the newest product started marketing on August 16, 2026.
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- Companies listing it
- 18
- Products
- 33
- Generic (ANDA) products
- 33 (100.0%)
- Application numbers
- 12
- Routes
- Oral, Rectal
- Brand names
- Kristalose, Enulose, Constulose, Generlac
- openFDA record search
- api.fda.gov
Companies that list lactulose
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Pai Holdings, LLC DBA Pai Pharma | 6 | solution; powder, for solution | Generic drugs (ANDA) | March 17, 2025 |
| Chartwell RX, LLC | 4 | solution | Generic drugs (ANDA) | November 23, 2018 |
| Actavis Pharma, Inc. | 2 | solution | Generic drugs (ANDA) | February 28, 2011 |
| Apozeal Pharmaceuticals Inc | 2 | solution | Generic drugs (ANDA) | December 20, 2024 |
| Chartwell Governmental & Specialty RX, LLC. | 2 | solution | Generic drugs (ANDA) | November 23, 2018 |
| Cumberland Assured Products Inc. | 2 | powder, for solution | Generic drugs (ANDA) | September 1, 2025 |
| Cumberland Pharmaceuticals Inc. | 2 | powder, for solution | Generic drugs (ANDA) | January 20, 2012 |
| Foxland Pharmaceuticals, Inc. | 2 | solution | Generic drugs (ANDA) | February 7, 2025 |
| Trifluent Pharma, LLC | 2 | powder, for solution | Generic drugs (ANDA) | September 13, 2025 |
| American Health Packaging | 1 | solution | Generic drugs (ANDA) | August 16, 2026 |
| Atlantic Biologicals Corp. | 1 | solution | Generic drugs (ANDA) | December 3, 2019 |
| Bryant Ranch Prepack | 1 | solution | Generic drugs (ANDA) | February 28, 2011 |
| Cardinal Health 107, LLC | 1 | solution | Generic drugs (ANDA) | May 3, 2019 |
| Fresenius Kabi Austria GmbH | 1 | solution | Generic drugs (ANDA) | December 10, 2012 |
| Lannett Company, Inc. | 1 | solution | Generic drugs (ANDA) | July 26, 2001 |
| Proficient Rx LP | 1 | solution | Generic drugs (ANDA) | December 3, 2019 |
| Sun Pharmaceutical Industries, Inc. | 1 | solution | Generic drugs (ANDA) | June 2, 2025 |
| Xttrium Laboratories, Inc. | 1 | solution | Generic drugs (ANDA) | July 1, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Solution | 25 | 75.8% |
| Powder, for solution | 8 | 24.2% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 33 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Osmotic Laxative | 33 |
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.