CONCERTA

Janssen Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Apr 20, 2026
Approval ID: 1a88218c-5b18-4220-8f56-526de1a276cd
Products: 4 registered
Version: 30

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use CONCERTA safely and effectively. See full prescribing information for CONCERTA. CONCERTA (methylphenidate hydrochloride) extended-release tablets, for oral use, CII Initial U.S. Approval: 2000

Quick Stats

Total Products4

Labelers2

Label Sections24

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.