Drug
Who makes dextromethorphan hydrobromide and quinidine sulfate?
4 companies list dextromethorphan hydrobromide and quinidine sulfate as a human prescription drug, including under the names Nuedexta. Forms: capsule; capsule, gelatin coated. 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 dextromethorphan hydrobromide and quinidine sulfate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Otsuka America Pharmaceutical, Inc.Japan | capsule, gelatin coated | NDANDA021879 | 1 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule | ANDAANDA202934 | 1 | 6 |
| Camber Pharmaceuticals, Inc.United States | capsule | ANDAANDA218426 | 1 | 1 |
| Avanir Pharmaceuticals, Inc. | capsule, gelatin coated | NDANDA021879 | 1 | 0 |
Enquiry
Common questions
- Who makes dextromethorphan hydrobromide and quinidine sulfate?
- 4 companies list dextromethorphan hydrobromide and quinidine sulfate as a human prescription drug in the openFDA NDC Directory, led by Otsuka America Pharmaceutical, Inc., Teva Pharmaceutical Industries Ltd., Camber Pharmaceuticals, Inc., Avanir 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 Nuedexta?
- 2 companies list dextromethorphan hydrobromide and quinidine sulfate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.