FDA label
What is Hysingla ER used for?
Hysingla ER contains hydrocodone. The FDA-approved uses below are 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: “HYSINGLA ER is 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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Hysingla ER, tablet, extended release
Indications and Usage, quoted from the label by Knoa Pharma LLC (NDA206627). Cross-references to other label sections are left out.
HYSINGLA ER is 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 HYSINGLA ER, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- HYSINGLA ER is not indicated as an as-needed (prn) analgesic.
Source: DailyMed label, set id b7d23ac2-e776-9f62-3290-c64c2d6eb353, version 17, effective May 29, 2026. NDC 59011-271, one of 6 listings for this product.
Questions
What is Hysingla ER used for?
The FDA label says: “HYSINGLA ER is 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 Hysingla ER?
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.
More on Hysingla ER
- Is Hysingla ER a controlled substance?Schedule II
- Generic for Hysingla ERFDA Orange Book
- What is Hydrocodone used for?FDA label uses
- Is Hydrocodone a controlled substance?Schedule II
- Generic for Zohydro ERFDA Orange Book
- Generic for Vantrela ERFDA Orange Book
- Opioid Agonists listFDA drug class
- NDC 59011-271Hysingla ER NDC record
- NDC 59011-272Hysingla ER NDC record
- NDC 59011-273Hysingla ER NDC record
- Schedule II drugs listDEA schedule