Data / Drug companies / Tramadol hydrochloride and acetaminophen
Tramadol hydrochloride and acetaminophen: 13 companies and 15 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Tramadol hydrochloride and acetaminophen is listed in the FDA National Drug Code Directory by 13 companies, with 15 products in commercial distribution. 15 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on August 28, 2025.
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- Companies listing it
- 13
- Products
- 15
- Generic (ANDA) products
- 15 (100.0%)
- Application numbers
- 3
- Controlled substance schedule
- Schedule IV
- Routes
- Oral
- openFDA record search
- api.fda.gov
Companies that list tramadol hydrochloride and acetaminophen
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Asclemed USA, Inc. | 2 | tablet, film coated; tablet | Generic drugs (ANDA) | December 15, 2012 |
| Bryant Ranch Prepack | 2 | tablet, film coated; tablet | Generic drugs (ANDA) | March 22, 2017 |
| Amneal Pharmaceuticals of New York LLC | 1 | tablet | Generic drugs (ANDA) | December 17, 2009 |
| Aurobindo Pharma Limited | 1 | tablet, film coated | Generic drugs (ANDA) | March 22, 2017 |
| AvPAK | 1 | tablet | Generic drugs (ANDA) | January 14, 2015 |
| Bryant Ranch Prepack | 1 | tablet, film coated | Generic drugs (ANDA) | March 22, 2017 |
| Direct_Rx | 1 | tablet, film coated | Generic drugs (ANDA) | September 14, 2022 |
| Medsource Pharmaceuticals | 1 | tablet, film coated | Generic drugs (ANDA) | March 22, 2017 |
| Preferred Pharmaceuticals Inc. | 1 | tablet | Generic drugs (ANDA) | January 29, 2021 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | December 17, 2009 |
| Proficient Rx LP | 1 | tablet, film coated | Generic drugs (ANDA) | March 22, 2017 |
| Remedyrepack Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | August 28, 2025 |
| St. Mary's Medical Park Pharmacy | 1 | tablet, film coated | Generic drugs (ANDA) | September 2, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 9 | 60% |
| Tablet | 6 | 40% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 15 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Agonist | 15 |
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.