Data / Drug companies / Naloxone hydrochloride
Naloxone hydrochloride: 40 companies and 80 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Naloxone hydrochloride is listed in the FDA National Drug Code Directory by 40 companies, with 80 products in commercial distribution. 73 of the products (91.2%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; spray; injection, and the newest product started marketing on October 28, 2026.
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- Companies listing it
- 40
- Products
- 80
- Generic (ANDA) products
- 73 (91.2%)
- Application numbers
- 29
- Routes
- Intramuscular, Subcutaneous, Intravenous, Nasal, Parenteral
- Brand names
- Narcan, Narcan, Rextovy, Zimhi, RiVive
- openFDA record search
- api.fda.gov
Companies that list naloxone hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| HF Acquisition Co LLC, DBA HealthFirst | 11 | injection, solution; injection | Generic drugs (ANDA) | July 30, 2023 |
| Medical Purchasing Solutions, LLC | 8 | injection, solution; injection | Generic drugs (ANDA) | January 29, 2021 |
| A-S Medication Solutions | 5 | spray; injection, solution | Generic drugs (ANDA) | July 30, 2023 |
| International Medication Systems, Limited | 4 | injection; spray | Generic drugs (ANDA) | May 7, 2024 |
| Eugia US LLC | 3 | injection, solution | Generic drugs (ANDA) | January 14, 2021 |
| Henry Schein, Inc. | 3 | injection, solution; injection | Generic drugs (ANDA) | October 28, 2025 |
| Hospira, Inc. | 3 | injection, solution | Generic drugs (ANDA) | September 23, 2005 |
| Mylan Institutional LLC | 3 | injection, solution | Generic drugs (ANDA) | December 2, 2022 |
| Baxter Healthcare Corporation | 2 | injection, solution | Generic drugs (ANDA) | November 7, 2022 |
| Fresenius Kabi USA, LLC | 2 | injection, solution | Generic drugs (ANDA) | April 2, 2024 |
| Hikma Pharmaceuticals USA Inc. | 2 | injection | Generic drugs (ANDA) | July 25, 2025 |
| Lifestar Pharma LLC | 2 | injection, solution | Generic drugs (ANDA) | February 19, 2026 |
| ProPharma Distribution | 2 | injection, solution | Generic drugs (ANDA) | August 8, 2017 |
| Proficient Rx LP | 2 | spray | New drug applications (NDA) | June 21, 2022 |
| Remedyrepack Inc. | 2 | injection; injection, solution | Generic drugs (ANDA) | October 28, 2026 |
| Somerset Therapeutics, LLC | 2 | injection, solution | Generic drugs (ANDA) | August 8, 2017 |
| Actavis Pharma, Inc. | 1 | spray, metered | Generic drugs (ANDA) | January 17, 2025 |
| Advanced Rx of Tennessee, LLC | 1 | spray | Generic drugs (ANDA) | June 27, 2024 |
| Amerisource Bergen | 1 | spray | Generic drugs (ANDA) | March 12, 2025 |
| Amneal Pharmaceuticals NY LLC | 1 | spray | Generic drugs (ANDA) | April 24, 2024 |
| Asclemed USA, Inc. | 1 | spray, metered | Generic drugs (ANDA) | September 23, 2024 |
| AvKARE | 1 | spray | Generic drugs (ANDA) | May 1, 2024 |
| Baxter Healthcare Corporation | 1 | injection, solution | Generic drugs (ANDA) | June 3, 2025 |
| BluePoint Laboratories | 1 | spray | Generic drugs (ANDA) | May 1, 2025 |
| Bpi Labs LLC | 1 | injection, solution | Generic drugs (ANDA) | November 15, 2023 |
| Bryant Ranch Prepack | 1 | spray | Generic drugs (ANDA) | July 30, 2023 |
| CVS Woonsocket Prescription Center, Incorporated | 1 | spray | Generic drugs (ANDA) | April 24, 2024 |
| Dr. Reddy's Laboratories Inc. | 1 | injection | Generic drugs (ANDA) | March 18, 2020 |
| Emergent Devices Inc. | 1 | spray | New drug applications (NDA) | January 24, 2017 |
| Harm Reduction Therapeutics, Inc. | 1 | spray | New drug applications (NDA) | January 2, 2024 |
| Kaleo, Inc | 1 | injection, solution | New drug applications (NDA) | February 28, 2022 |
| NorthStar RxLLC | 1 | injection, solution | Generic drugs (ANDA) | July 1, 2024 |
| Padagis Israel Pharmaceuticals Ltd | 1 | spray | Generic drugs (ANDA) | July 30, 2023 |
| Par Health USA, LLC | 1 | injection | Generic drugs (ANDA) | November 5, 2024 |
| Sina Health Inc | 1 | injection, solution | Generic drugs (ANDA) | August 8, 2017 |
| Sportpharm LLC | 1 | spray, metered | Generic drugs (ANDA) | September 23, 2024 |
| Strategic Sourcing Services LLC | 1 | spray | Generic drugs (ANDA) | April 1, 2025 |
| Teva Pharmaceuticals, Inc. | 1 | spray, metered | Generic drugs (ANDA) | September 23, 2024 |
| Walgreen Company | 1 | spray | Generic drugs (ANDA) | April 24, 2024 |
| Zmi Pharma Inc. | 1 | injection, solution | New drug applications (NDA) | January 15, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 42 | 52.5% |
| Spray | 19 | 23.8% |
| Injection | 15 | 18.8% |
| Spray, metered | 4 | 5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 73 | 91.2% |
| New drug applications (NDA) | 7 | 8.8% |
Pharmacologic classes
| Class | Products |
|---|---|
| Opioid Antagonist | 80 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.