{"@type": "dcat:Dataset", "accessLevel": "public", "accrualPeriodicity": "R/P1Y", "bureauCode": ["009:10"], "contactPoint": {"@type": "vcard:Contact", "fn": "Division of Drug Information", "hasEmail": "mailto:druginfo@fda.hhs.gov"}, "description": "Hydrocodone Bitartrate and Acetaminophen is a prescription medication used to relieve moderate to severe pain. It combines hydrocodone, an opioid pain reliever, with acetaminophen, a fever reducer and pain reliever. Available as oral tablets in strengths of 5mg/325mg, 7.5mg/325mg, and 10mg/325mg hydrocodone/acetaminophen. Manufactured by Granules Pharmaceuticals Inc. as a generic version. It's a Schedule II controlled substance. This information was generated using AI and is provided for informational and research purposes only.", "distribution": [{"@type": "dcat:Distribution", "description": "\n        Access the FDA dataset for Hydrocodone bitartrate and acetaminophen \u2014 ANDA 211023 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211023", "mediaType": "text/html", "title": "Hydrocodone bitartrate and acetaminophen"}], "identifier": "ANDA211023", "issued": "2016-09-16", "keyword": ["drug-information", "fda", "health-care", "prescription-drugs", "drug-manufacturers"], "landingPage": "https://www.fda.gov/drugs", "license": "https://open.fda.gov/license", "modified": "2025-03-17", "programCode": ["009:002"], "publisher": {"@type": "org:Organization", "name": "U.S. Food and Drug Administration"}, "theme": ["FDA"], "title": "Hydrocodone bitartrate and acetaminophen"}