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.
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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 |
