Drug
Who makes buprenorphine hydrochloride and naloxone hydrochloride dihydrate?
10 companies list buprenorphine hydrochloride and naloxone hydrochloride dihydrate as a human prescription drug. Forms: tablet. 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 dihydrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| CLINICAL SOLUTIONS WHOLESALE, LLCUnited States | tablet | ANDAANDA203326, ANDA207000, ANDA209069 | 5 | 1 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA203326, ANDA207000, ANDA209069 | 4 | 1 |
| SpecGx LLCUnited States | tablet | ANDAANDA207000 | 2 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet | ANDAANDA209069 | 2 | 2 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA203326 | 2 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA203326 | 2 | 1 |
| Unit Dose Solutions, Inc.United States | tablet | ANDAANDA207000 | 2 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA203326 | 2 | 0 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA209069 | 1 | 1 |
| RedPharm DrugUnited States | tablet | ANDAANDA209069 | 1 | 1 |
Enquiry
Common questions
- Who makes buprenorphine hydrochloride and naloxone hydrochloride dihydrate?
- 10 companies list buprenorphine hydrochloride and naloxone hydrochloride dihydrate as a human prescription drug in the openFDA NDC Directory, led by CLINICAL SOLUTIONS WHOLESALE, LLC, Bryant Ranch Prepack, SpecGx LLC, ACCORD HEALTHCARE LIMITED, Golden State Medical Supply 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 buprenorphine hydrochloride and naloxone hydrochloride dihydrate?
- 10 companies list buprenorphine hydrochloride and naloxone hydrochloride dihydrate 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.