Drug
Who makes naloxone hcl?
3 companies list naloxone hcl as a human prescription drug, including under the names KLOXXADO, REZENOPY. Forms: spray. Routes: nasal.
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 naloxone hcl
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | spray | NDANDA212045 | 1 | 4 |
| HF Acquisition Co LLCUnited States | spray | ANDAANDA211951 | 1 | 1 |
| Scienture LLC | spray | NDANDA215487 | 1 | 0 |
Bulk ingredient listings
- Veranova, L.P.United States · 1 NDC
Enquiry
Common questions
- Who makes naloxone hcl?
- 3 companies list naloxone hcl as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., HF Acquisition Co LLC, Scienture 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 KLOXXADO?
- 1 company lists naloxone hcl 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.
- Who supplies naloxone hcl active ingredient?
- 1 company lists naloxone hcl as a bulk ingredient, including Veranova, L.P..