Quick answers
- What is Omeprazole used for?
- The FDA-approved label (Prilosec, Covis Pharma US, Inc, March 19, 2024) says: “PRILOSEC is a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Omeprazole have a boxed warning?
- No. None of the 134 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Omeprazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Omeprazole been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started June 30, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Omeprazole?
- 44 companies list prescription products of Omeprazole in the FDA NDC Directory, including A-S Medication Solutions, Proficient Rx LP and Bryant Ranch Prepack.
What Omeprazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PRILOSEC is a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults • Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults • Treatment of active benign gastric ulcer in adults • Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older • Treatment of erosive esophagitis (EE) due to acid-mediated …
— FDA label: Prilosec, Covis Pharma US, Inc, effective March 19, 2024. Read the full label on DailyMed →
The FDA has 134 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 134 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, delayed release · Capsule, delayed release pellets · Granule, delayed release |
|---|---|
| Route | Oral |
| Prescription products | 176 in the FDA NDC Directory |
| Brand names | Prilosec |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| omeprazole 10 mg capsule, delayed release | Generic | $0.0731 per capsule |
| omeprazole 20 mg capsule, delayed release | Generic | $0.0305 per capsule |
| omeprazole 40 mg capsule, delayed release | Generic | $0.0496 per capsule |
| omeprazole magnesium 10 mg granule, delayed release | Brand: Prilosec | $14.79 per unit |
| omeprazole magnesium 2.5 mg granule, delayed release | Brand: Prilosec | $14.75 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions20 products
- Proficient Rx LP14 products
- Bryant Ranch Prepack13 products
- Aphena Pharma Solutions - Tennessee, LLC11 products
- NuCare Pharmaceuticals, Inc.9 products
- Golden State Medical Supply, Inc.6 products
- Dr. Reddy's Laboratories Limited6 products
- Northwind Health Company, LLC5 products
- Sandoz Inc5 products
- Preferred Pharmaceuticals Inc.5 products
- PD-Rx Pharmaceuticals, Inc.4 products
- Advanced Rx of Tennessee, LLC4 products
- NorthStar Rx LLC4 products
- St. Mary's Medical Park Pharmacy4 products
- Remedyrepack Inc.4 products
- Apotex Corp.4 products
- QPharma, Inc.4 products
- Asclemed USA, Inc.3 products
- Hawaii Repack, Inc.3 products
- Aurobindo Pharma Limited3 products
- Lannett Company, Inc.3 products
- Rising Pharma Holdings, Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- Zydus Lifesciences Limited3 products
- Xiromed, LLC3 products
- Quallent Pharmaceuticals Health LLC3 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Phoenix RX LLC2 products
- Chartwell RX, LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- American Health Packaging2 products
- Covis Pharma US, Inc2 products
- Boswell Pharmacy Services LLC d/b/a BPS Wholesale1 product
- Cardinal Health 107, LLC1 product
- Unit Dose Solutions, Inc.1 product
- Preferred Phharmaceuticals Inc.1 product
- Redpharm Drug1 product
- AvPAK1 product
- Major Pharmaceuticals1 product
- Quality Care Products, LLC1 product
- NuCarePharmaceuticals, Inc.1 product
- Coupler LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022056 PRILOSEC | Azurity | March 20, 2008 | 21, latest July 18, 2023 2023: Labeling · 2022: Labeling · 2020: Labeling |
Generic approvals (12)
- ANDA075410Lannett Co Inc · November 1, 2002
- ANDA075757Sandoz · January 28, 2003
- ANDA075576DR Reddys Labs Ltd · October 22, 2007
- ANDA076048Apotex · October 22, 2007
- ANDA076515Sandoz · January 21, 2009
- ANDA078490DR Reddys Labs Ltd · April 17, 2009
- ANDA091352Zydus Pharms USA Inc · November 19, 2012
- ANDA091672Glenmark Pharms Ltd · October 31, 2014
- ANDA203270Aurobindo Pharma · August 19, 2015
- ANDA203481Breckenridge · July 3, 2017
- ANDA204012Hetero Labs Ltd III · September 26, 2019
- ANDA212977Xiromed · December 10, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 30, 2025 · Class II · Ongoing · D-0525-2025
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Caym — Dr. Reddy's Laboratories, Inc.
-
March 15, 2021 · Class II · Terminated · D-0466-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland — Cardinal Health Inc.
-
September 16, 2013 · Class II · Terminated · D-009-2014
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43 — Kremers Urban Pharmaceuticals, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prilosec, Covis Pharma US, Inc, effective March 19, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →