Drug
Who makes naloxone hydrochloride?
23 companies list naloxone hydrochloride as a human prescription drug, including under the names Narcan, REXTOVY, ZIMHI. Forms: injection; injection, solution; spray. Routes: intramuscular, intravenous, nasal, parenteral, subcutaneous.
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 hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| HF Acquisition Co LLCUnited States | injection; injection, solution | ANDAANDA070172, ANDA070257, ANDA070299 | 10 | 1 |
| International Medication Systems, Ltd.United States | injection; injection, solution; spray | ANDA, NDAANDA072076, ANDA204997, ANDA207633 | 8 | 3 |
| Medical Purchasing Solutions, LLCUnited States | injection; injection, solution | ANDAANDA072076, ANDA207633, ANDA207634 | 8 | 1 |
| Baxter Healthcare CorporationUnited States | injection, solution | ANDAANDA214785, ANDA214792 | 3 | 16 |
| Hospira, Inc.United States | injection, solution | ANDAANDA070172, ANDA070256, ANDA070257 | 3 | 7 |
| Henry Schein, Inc.United States | injection; injection, solution | ANDAANDA070172, ANDA072076, ANDA218404 | 3 | 1 |
| Eugia US LLC | injection, solution | ANDAANDA212455, ANDA212456, ANDA213279 | 3 | 0 |
| Mylan Institutional Inc. | injection, solution | ANDAANDA204997, ANDA205014, ANDA213843 | 3 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA213573 | 2 | 6 |
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA212300 | 2 | 4 |
| ProPharma Distribution, LLC.United States | injection, solution | ANDAANDA207633, ANDA207634 | 2 | 3 |
| Proficient Rx LPUnited States | spray | ANDA, NDAANDA211951, NDA208411 | 2 | 1 |
| Somerset Therapeutics Private LimitedIndia | injection, solution | ANDAANDA207633, ANDA207634 | 2 | 1 |
| Lifestar Pharma LLC. | injection, solution | ANDAANDA218404 | 2 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | injection | ANDAANDA213209 | 1 | 15 |
| Par Health USA, LLCIndia | injection | ANDAANDA215964 | 1 | 5 |
| BPI Labs, DBA Ally LabsUnited States | injection, solution | ANDAANDA216977 | 1 | 2 |
| RemedyRepack, IncUnited States | injection | ANDAANDA072076 | 1 | 1 |
| Sina Health IncUnited States | injection, solution | ANDAANDA207633 | 1 | 1 |
| Emergent Devices Inc. | spray | NDANDA208411 | 1 | 0 |
| Kaleo, Inc. | injection, solution | NDANDA215457 | 1 | 0 |
| NorthStar RxLLC | injection, solution | ANDAANDA218404 | 1 | 0 |
| ZMI Pharma Inc. | injection, solution | NDANDA212854 | 1 | 0 |
Bulk ingredient listings
- FRANCOPIA · 3 NDC
- Sanofi Winthrop Industrie · 3 NDC
- Aspen Oss B.V.Netherlands · 1 NDC
- Saneca Pharmaceuticals a.s.Slovakia · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
33 unexpired patents list naloxone hydrochloride as the active ingredient, expiring between Dec 2026 and Jun 2041. Application holders: HARM REDUCTION THERAPEUTICS INC, HIKMA PHARMACEUTICALS USA INC, KALEO INC, SCIENTURE LLC, ZMI PHARMA INC.
Enquiry
Common questions
- Who makes naloxone hydrochloride?
- 23 companies list naloxone hydrochloride as a human prescription drug in the openFDA NDC Directory, led by HF Acquisition Co LLC, International Medication Systems, Ltd., Medical Purchasing Solutions, LLC, Baxter Healthcare Corporation, Hospira, 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 Narcan?
- 20 companies list naloxone hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 5 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies naloxone hydrochloride active ingredient?
- 6 companies list naloxone hydrochloride as a bulk ingredient, including FRANCOPIA, Sanofi Winthrop Industrie, Aspen Oss B.V., Saneca Pharmaceuticals a.s..