Data / Drug companies / Butalbital and acetaminophen
Butalbital and acetaminophen: 9 companies and 15 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Butalbital and acetaminophen is listed in the FDA National Drug Code Directory by 9 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; capsule, and the newest product started marketing on March 15, 2026.
The request: Get every company that lists butalbital and acetaminophen in the FDA NDC directory, with headquarters, website and number of employees. $10 of work on sign-up, no card.
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- Companies listing it
- 9
- Products
- 15
- Generic (ANDA) products
- 15 (100.0%)
- Application numbers
- 8
- Controlled substance schedule
- Schedule III
- Routes
- Oral
- Brand names
- Tencon, Allzital
- openFDA record search
- api.fda.gov
Companies that list butalbital and acetaminophen
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Amici Pharma, Inc. | 3 | tablet | Generic drugs (ANDA) | March 15, 2026 |
| Larken Laboratories, Inc. | 3 | tablet | Generic drugs (ANDA) | December 4, 2015 |
| Burel Pharmaceuticals, LLC | 2 | tablet | Generic drugs (ANDA) | December 1, 2022 |
| Quagen Pharmaceuticals LLC | 2 | tablet | Generic drugs (ANDA) | May 1, 2024 |
| Aarkish Pharmaceuticals NJ Inc. | 1 | tablet | Generic drugs (ANDA) | December 3, 2024 |
| Dr. Reddy's Laboratories Inc. | 1 | capsule | Generic drugs (ANDA) | September 1, 2024 |
| El Dorado Distributors LLC | 1 | tablet | Generic drugs (ANDA) | October 10, 2013 |
| Granules Pharmaceuticals Inc. | 1 | capsule | Generic drugs (ANDA) | January 20, 2020 |
| Par Health USA, LLC | 1 | tablet | Generic drugs (ANDA) | June 3, 1999 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 13 | 86.7% |
| Capsule | 2 | 13.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 15 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Barbiturate | 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.