Drug
Who makes buprenorphine hydrochloride and naloxone hydrochloride?
3 companies list buprenorphine hydrochloride and naloxone hydrochloride as a human prescription drug, including under the names Zubsolv. Forms: tablet; tablet, orally disintegrating. Routes: sublingual.
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 buprenorphine hydrochloride and naloxone hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Edenbridge Pharmaceuticals LLC. | tablet, orally disintegrating | NDANDA204242 | 6 | 0 |
| Orexo US, Inc. | tablet, orally disintegrating | NDANDA204242 | 6 | 0 |
| PAI Holdings, LLCUnited States | tablet | ANDAANDA204431 | 2 | 1 |
Enquiry
Common questions
- Who makes buprenorphine hydrochloride and naloxone hydrochloride?
- 3 companies list buprenorphine hydrochloride and naloxone hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Edenbridge Pharmaceuticals LLC., Orexo US, Inc., PAI Holdings, LLC. 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 Zubsolv?
- 1 company lists buprenorphine hydrochloride and naloxone hydrochloride 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.