Butalbital and acetaminophen
Butalbital and Acetaminophen is a prescription oral tablet combining butalbital (a barbiturate for muscle relaxation) and acetaminophen (a pain reliever) to treat tension headaches. Available in strengths like 325mg acetaminophen with 50mg butalbital, it's a controlled substance (Schedule III) manufactured by Burel Pharmaceuticals, LLC under ANDA214088. 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 | Butalbital and Acetaminophen is a prescription oral tablet combining butalbital (a barbiturate for muscle relaxation) and acetaminophen (a pain reliever) to treat tension headaches. Available in strengths like 325mg acetaminophen with 50mg butalbital, it's a controlled substance (Schedule III) manufactured by Burel Pharmaceuticals, LLC under ANDA214088. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Butalbital and acetaminophen",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Butalbital and acetaminophen — ANDA 214088 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214088"
}
]
|
| identifier | ANDA214088 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"health-care",
"medications",
"pharmaceuticals",
"prescription-drugs"
]
|
| 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 | Butalbital and acetaminophen |
