FDA label
What is hydrocodone used for?
The FDA-approved uses of hydrocodone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.”
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Hydrocodone Bitartrate, tablet, extended release
Indications and Usage, quoted from the label by Alvogen Inc. (ANDA208269). Cross-references to other label sections are left out.
Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.
Limitations of Use
- Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic.
Source: DailyMed label, set id f7b55d14-0980-b680-8ceb-7489ff65455e, version 8, effective October 7, 2025. NDC 47781-392, one of 7 listings for this product.
Questions
What is hydrocodone used for?
The FDA label says: “Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.”
What drug class is hydrocodone?
FDA lists hydrocodone in the Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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