Data / Drug companies / Theophylline
Theophylline: 24 companies and 43 products in the FDA NDC directory
Theophylline is listed in the FDA National Drug Code Directory by 24 companies, with 43 products in commercial distribution. 43 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, extended release; solution, and the newest product started marketing on March 26, 2025.
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- Companies listing it
- 24
- Products
- 43
- Generic (ANDA) products
- 43 (100.0%)
- Application numbers
- 18
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list theophylline
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | 4 | tablet, extended release | Generic drugs (ANDA) | June 3, 2021 |
| Ajanta Pharma USA Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | March 26, 2025 |
| Alembic Pharmaceuticals Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | January 29, 2016 |
| Alembic Pharmaceuticals Limited | 2 | tablet, extended release | Generic drugs (ANDA) | November 1, 2010 |
| Amneal Pharmaceuticals NY LLC | 2 | tablet, extended release | Generic drugs (ANDA) | March 27, 2023 |
| Camber Pharmaceuticals, Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | September 8, 2023 |
| Chartwell RX, LLC | 2 | tablet, extended release; solution | Generic drugs (ANDA) | June 27, 2022 |
| Golden State Medical Supply, Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | April 21, 2006 |
| Harman Finochem Limited | 2 | tablet, extended release | Generic drugs (ANDA) | May 31, 2024 |
| Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | June 27, 2022 |
| Leading Pharma, LLC | 2 | tablet, extended release | Generic drugs (ANDA) | May 15, 2023 |
| PD-Rx Pharmaceuticals, Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | September 27, 2024 |
| Pai Holdings, LLC DBA Pai Pharma | 2 | solution | Generic drugs (ANDA) | December 16, 2016 |
| Strides Pharma Science Limited | 2 | tablet, extended release | Generic drugs (ANDA) | September 27, 2024 |
| Teva Pharmaceuticals, Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | January 27, 2023 |
| Viona Pharmaceuticals Inc | 2 | tablet, extended release | Generic drugs (ANDA) | May 25, 2024 |
| Zydus Lifesciences Limited | 2 | tablet, extended release | Generic drugs (ANDA) | May 25, 2024 |
| Atlantic Biologicals Corp. | 1 | solution | Generic drugs (ANDA) | August 2, 2012 |
| AvKARE | 1 | tablet, extended release | Generic drugs (ANDA) | April 13, 2023 |
| Bionpharma Inc. | 1 | tablet, extended release | Generic drugs (ANDA) | October 12, 2023 |
| Bryant Ranch Prepack | 1 | solution | Generic drugs (ANDA) | August 2, 2012 |
| Bryant Ranch Prepack | 1 | solution | Generic drugs (ANDA) | August 2, 2012 |
| Chartwell Governmental & Specialty RX, LLC. | 1 | solution | Generic drugs (ANDA) | April 13, 2011 |
| Cranbury Pharmaceuticals, LLC | 1 | solution | Generic drugs (ANDA) | August 2, 2012 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, extended release | 35 | 81.4% |
| Solution | 8 | 18.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 43 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Methylxanthine | 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.