Active ingredient
Naloxone
93 finished FDA listings contain Naloxone as their only active ingredient; 107 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- NALOXONE, NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE
- Dosage forms
- Inhalant, Injection, Injection, Solution, Spray, Spray, Metered
- Routes
- Intramuscular, Intravenous, Nasal, Parenteral, Subcutaneous
- Manufacturers / labelers
- 48
- Strengths listed
- .4 mg/ml · 1 mg/ml · 10 mg/.11ml · 10 mg/.4ml · 3 mg/.1ml · 4 mg/.1ml · 4 mg/.25ml · 5 mg/.5ml · 8 mg/.1ml
- Brand names in FDA listings
- Kloxxado, Naloxone Hydrochloride, Naloxone Hydrochloride Injection, Usp, Auto-Injector, Narcan, Rextovy, Rezenopy, Rivive, Zimhi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7242
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 070299 | HIKMA | 1985-10-22 | 5 |
| ANDA 070172 | HOSPIRA | 1986-04-18 | 3 |
| ANDA 070256 | HOSPIRA | 1987-01-07 | 2 |
| ANDA 070257 | HOSPIRA | 1987-01-07 | 2 |
| ANDA 072076 | INTL MEDICATION | 1988-03-24 | 8 |
| ANDA 204997 | MYLAN INSTITUTIONAL | 2014-03-06 | 2 |
| NDA 208411 | EMERGENT | 2015-11-18 | 8 |
| ANDA 205014 | MYLAN INSTITUTIONAL | 2016-06-29 | 1 |
| ANDA 207634 | SOMERSET THERAPS LLC | 2017-07-26 | 5 |
| ANDA 207633 | SOMERSET THERAPS LLC | 2017-08-08 | 5 |
| ANDA 209522 | TEVA PHARMS USA | 2019-04-19 | 4 |
| ANDA 212455 | EUGIA PHARMA | 2019-10-15 | 3 |
| ANDA 212456 | EUGIA PHARMA | 2019-11-04 | 2 |
| ANDA 213209 | DR REDDYS | 2020-03-16 | 3 |
| ANDA 213279 | EUGIA PHARMA | 2021-01-14 | 3 |
| ANDA 214785 | BAXTER HLTHCARE CORP | 2021-01-29 | 3 |
| NDA 212045 | HIKMA | 2021-04-29 | 1 |
| NDA 212854 | ZMI PHARMA | 2021-10-15 | 1 |
| NDA 215457 | KALEO INC | 2022-02-28 | 1 |
| ANDA 213843 | MYLAN LABS LTD | 2022-06-09 | 1 |
| ANDA 212300 | HIKMA | 2022-06-10 | 2 |
| ANDA 211951 | PADAGIS ISRAEL | 2022-06-21 | 11 |
| ANDA 215964 | PH HEALTH | 2022-07-29 | 1 |
| ANDA 214792 | BAXTER HLTHCARE CORP | 2022-11-07 | 1 |
| NDA 208969 | AMPHASTAR PHARMS INC | 2023-03-07 | 1 |
| NDA 217722 | HARM REDUCTION THERP | 2023-07-28 | 1 |
| ANDA 216977 | BPI LABS | 2023-10-06 | 1 |
| ANDA 218404 | MANKIND PHARMA | 2024-02-29 | 4 |
| ANDA 213573 | FRESENIUS KABI USA | 2024-04-02 | 2 |
| NDA 215487 | SCIENTURE | 2024-04-19 | 1 |
| ANDA 217992 | AMNEAL | 2024-04-23 | 5 |
Official labeling on DailyMed
- NALOXONE HYDROCHLORIDE INJECTION [DR. REDDY'S LABORATORIES, INC.] · version 9 · 2026-09-07
- NALOXONE HYDROCHLORIDE SPRAY [AMNEAL PHARMACEUTICALS LLC] · version 12 · 2026-08-27
- NARCAN (NALOXONE HYDROCHLORIDE NASAL) SPRAY [EMERGENT DEVICES INC.] · version 4 · 2026-08-24
- NALOXONE HYDROCHLORIDE SPRAY, METERED [SPORTPHARM LLC] · version 1 · 2026-07-06
- NALOXONE HYDROCHLORIDE (NALXONE HYDROCHLORIDE) INJECTION [CIVICA, INC.] · version 5 · 2026-07-01
- NALOXONE HYDROCHLORIDE SPRAY [BLUEPOINT LABORATORIES] · version 3 · 2026-06-18
- NALOXONE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2026-06-15
- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] · version 8 · 2026-06-04
- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] · version 35 · 2026-05-28
- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 4 · 2026-05-15
- NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] · version 10 · 2026-05-13
- NARCAN (NALOXONE HYDROCHLORIDE NASAL) SPRAY [SPORTPHARM LLC] · version 2 · 2026-04-27
Showing the 12 most recent of 89 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.