FDA
Naloxone Hydrochloride
The FDA lists this product in 60 strengths and forms.
Indications
Use(s) to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life
Warnings and precautions
Warnings When using this product some people may experience symptoms when they wake up, such as shaking, sweating, nausea, or feeling angry. This is to be expected.
Composition
- Active ingredients
- NALOXONE HYDROCHLORIDE 4MG/SPRAY
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- NALOXONE HYDROCHLORIDE 0.4MG/ML · InjectableANDA205014-001 · Prescription
- NALOXONE HYDROCHLORIDE 0.4MG/ML · InjectableANDA207633-001 · Prescription
- NALOXONE HYDROCHLORIDE 0.4MG/ML · InjectableANDA208872-001 · Prescription
- NALOXONE HYDROCHLORIDE 0.4MG/ML · InjectableANDA214785-001 · Prescription
- NALOXONE HYDROCHLORIDE 1MG/ML · InjectableANDA214785-002 · Prescription
- NALOXONE HYDROCHLORIDE 8MG/SPRAY · SprayANDA216719-001 · Discontinued
- NALOXONE HYDROCHLORIDE 0.4MG/ML · InjectableANDA070256-001 · Prescription
- NALOXONE HYDROCHLORIDE 0.02MG/ML · InjectableANDA071671-001 · Discontinued
- NALOXONE HYDROCHLORIDE 0.02MG/ML · InjectableANDA071672-001 · Discontinued
At a glance
- Brand name
- Naloxone Hydrochloride
- Route
- Nasal
- Dosage form
- Spray, metered
- Applicant
- Amneal
- Status
- Over the counter
- FDA approval
- 23 Apr 2024
- Application
- ANDA217992-001