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Esomeprazole Magnesium
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cytochrome P450 2C19 Inhibitors [MoA] | MoA | All 93 members |
| Proton Pump Inhibitor [EPC] | EPC | All 74 members |
| Proton Pump Inhibitors [MoA] | MoA | All 74 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 212507-001 | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED RELEASE | ESOMEPRAZOLE MAGNESIUM | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | June 2, 2020 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260210). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.
Purpose
openFDA Drug LabelingPurpose Acid reducer
Dosage and Administration
openFDA Drug LabelingDirections adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 14-Day Course of Treatment • swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules • do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
Warnings
openFDA Drug LabelingWarnings Allergy alert: Do not use if you are allergic to esomeprazole Esomeprazole may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Do Not Use
openFDA Drug LabelingDo not use if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain. Note: These may be signs of a serious condition. See your doctor.
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain
Stop Use
openFDA Drug LabelingStop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain
Active Ingredient
openFDA Drug LabelingActive ingredient (in each capsule) Esomeprazole 20 mg (Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium trihydrate USP)
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 69168-472-14 | 69168-472 | Allegiant Health | 1 BOTTLE in 1 CARTON (69168-472-14) / 14 CAPSULE in 1 BOTTLE | May 15, 2025 |
| 69168-472-15 | 69168-472 | Allegiant Health | 14 CAPSULE in 1 BOTTLE (69168-472-15) | May 15, 2025 |
| 69168-472-42 | 69168-472 | Allegiant Health | 3 BOTTLE in 1 CARTON (69168-472-42) / 14 CAPSULE in 1 BOTTLE | May 15, 2025 |
| 69168-472-61 | 69168-472 | Allegiant Health | 1 BOTTLE in 1 CARTON (69168-472-61) / 14 CAPSULE in 1 BOTTLE | May 15, 2025 |
| 69168-472-62 | 69168-472 | Allegiant Health | 3 BOTTLE in 1 CARTON (69168-472-62) / 14 CAPSULE in 1 BOTTLE | May 15, 2025 |
| 17228-5020-9 | 17228-5020 | AstraZeneca AB | 20000 CAPSULE in 1 DRUM (17228-5020-9) | March 19, 2001 |
| 17228-5040-9 | 17228-5040 | AstraZeneca AB | 16000 CAPSULE in 1 DRUM (17228-5040-9) | March 19, 2001 |
| 11014-0382-2 | 11014-0382 | Catalent Pharma Solutions, LLC | 1 BAG in 1 DRUM (11014-0382-2) / 347000 CAPSULE in 1 BAG | January 1, 2025 |
| 11014-0695-2 | 11014-0695 | Catalent Pharma Solutions, LLC | 1 BAG in 1 DRUM (11014-0695-2) / 236000 CAPSULE in 1 BAG | January 1, 2025 |
| 11014-0696-2 | 11014-0696 | Catalent Pharma Solutions, LLC | 1 BAG in 1 DRUM (11014-0696-2) / 207000 CAPSULE in 1 BAG | January 1, 2025 |
| 73581-014-42 | 73581-014 | YYBA CORP | 3 BOTTLE in 1 CARTON (73581-014-42) / 14 CAPSULE in 1 BOTTLE | April 1, 2026 |
| 69168-472 | 69168-472 | Allegiant Health | — | May 15, 2025 |
| 17228-5020 | 17228-5020 | AstraZeneca AB | — | March 19, 2001 |
| 17228-5040 | 17228-5040 | AstraZeneca AB | — | March 19, 2001 |
| 11014-0382 | 11014-0382 | Catalent Pharma Solutions, LLC | — | March 19, 2007 |
| 11014-0695 | 11014-0695 | Catalent Pharma Solutions, LLC | — | January 4, 2019 |
| 11014-0696 | 11014-0696 | Catalent Pharma Solutions, LLC | — | January 4, 2019 |
| 73581-014 | 73581-014 | YYBA CORP | — | April 1, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.