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National Drug Schedules: Final Recommendations for Non-prescription Esomeprazole 20 mg

National Drug Schedule

The interim recommendations made by the National Drug Scheduling Advisory Committee (NDSAC) on June 1, 2025, that:

  • Esomeprazole or its salts, for human use, when sold for the 14-day treatment for frequent heartburn at a daily dose of 20 mg, in package sizes of no more than 280 mg of esomeprazole, remain in Schedule III.
  • Esomeprazole or its salts, for human use, when sold for the 14-day treatment for frequent heartburn at a daily dose of 20 mg, in package sizes containing greater than 280 mg of esomeprazole, be granted Schedule II status.

were finalized effective July 22, 2025. Final approval of the interim recommendations was made by NAPRA’s Board of Directors. In this case, NAPRA did not receive any comments during the 30-day consultation period. The National Drug Schedules will be revised accordingly.

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