Drug
Who makes butalbital and acetaminophen?
9 companies list butalbital and acetaminophen as a human prescription drug, including under the names ALLZITAL, Tencon. Forms: capsule; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing butalbital and acetaminophen
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Larken Laboratories, IncUnited States | tablet | ANDAANDA203484 | 3 | 1 |
| Amici Pharmaceuticals, LLC. | tablet | ANDAANDA214088 | 3 | 0 |
| QUAGEN PHARMACEUTICALS LLCUnited States | tablet | ANDAANDA214291, ANDA214305 | 2 | 2 |
| Burel Pharmaceuticals, LLC | tablet | ANDAANDA214088 | 2 | 0 |
| Granules Pharmaceuticals Inc.India | capsule | ANDAANDA213115 | 1 | 8 |
| Par Health USA, LLCIndia | tablet | ANDAANDA089987 | 1 | 5 |
| Aarkish Pharmaceuticals NJ IncUnited States | tablet | ANDAANDA214955 | 1 | 1 |
| Dr. Reddy's Labratories Inc. | capsule | ANDAANDA207313 | 1 | 0 |
| El Dorado Distributors LLC | tablet | ANDAANDA089987 | 1 | 0 |
Enquiry
Common questions
- Who makes butalbital and acetaminophen?
- 9 companies list butalbital and acetaminophen as a human prescription drug in the openFDA NDC Directory, led by Larken Laboratories, Inc, Amici Pharmaceuticals, LLC., QUAGEN PHARMACEUTICALS LLC, Burel Pharmaceuticals, LLC, Granules Pharmaceuticals Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic butalbital and acetaminophen?
- 9 companies list butalbital and acetaminophen under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.