Hysingla ER

Purdue Pharma LP🇺🇸 United States

FDA Page

Effective Date: May 29, 2026
Approval ID: b7d23ac2-e776-9f62-3290-c64c2d6eb353
Products: 7 registered
Version: 17

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use HYSINGLA ER safely and effectively. See full prescribing information for HYSINGLA ER. HYSINGLA ER (hydrocodone bitartrate) extended-release tablets, for oral use, CII Initial U.S. Approval: 1943

Quick Stats

Total Products7

Labelers3

Label Sections47

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.