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Treats active duodenal ulcer. Sold as Prilosec Otc, Prilosec. Every FDA application for this active ingredient: 2 branded and 9 generic.
As of Nov 15, 2026, FDA lists 11 applications for Omeprazole Magnesium (sold as Prilosec Otc, Prilosec), first approved Jun 20, 2003, with 1 new use approved and 0 published complete response letters.
First approved: Jun 20, 2003
Applications: 11
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $3.2M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Prilosec
Part D
$3.2M
-1%
812
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
OMEPRAZOLE DR 10 MG CAPSULE: $0.073 per unitGeneric · +5% in a year
OMEPRAZOLE DR 20 MG CAPSULE: $0.030 per unitGeneric · -2% in a year
OMEPRAZOLE DR 40 MG CAPSULE: $0.050 per unitGeneric · -4% in a year
PRILOSEC DR 10 MG SUSPENSION: $14.79 per unitBrand · +3% in a year
PRILOSEC DR 2.5 MG SUSPENSION: $14.75 per unitBrand · +2% in a year
Clinical Trials
91 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Astrazeneca
Aurobindo Pharma