Naloxone hydrochloride
Naloxone Hydrochloride is an injectable prescription medication that reverses opioid overdoses by blocking opioid effects in the body. Available in strengths of 0.4 mg/mL and 1 mg/mL, it is administered via intramuscular, intravenous, or subcutaneous injection. Manufactured by Hikma Pharmaceuticals USA Inc. under ANDA212300. This information was generated using AI and is provided for informational and research purposes only.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1Y |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "Division of Drug Information",
"@type": "vcard:Contact",
"hasEmail": "mailto:druginfo@fda.hhs.gov"
}
|
| description | Naloxone Hydrochloride is an injectable prescription medication that reverses opioid overdoses by blocking opioid effects in the body. Available in strengths of 0.4 mg/mL and 1 mg/mL, it is administered via intramuscular, intravenous, or subcutaneous injection. Manufactured by Hikma Pharmaceuticals USA Inc. under ANDA212300. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Naloxone hydrochloride",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Naloxone hydrochloride — ANDA 213209 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213209"
}
]
|
| identifier | ANDA213209 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-information",
"drug-manufacturers",
"fda",
"medications"
]
|
| landingPage | https://www.fda.gov/drugs |
| license | https://open.fda.gov/license |
| modified | 2025-03-17 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Naloxone hydrochloride |
