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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 |
|---|---|---|---|---|---|---|---|
| 214473-001 | ESOMEPRAZOLE MAGNESIUM | TABLET, DELAYED RELEASE | ESOMEPRAZOLE MAGNESIUM | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | July 12, 2023 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260212). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses 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 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day swallow whole. Do not crush or chew tablets. 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. Other information read the directions and warnings before use keep the carton. It contains important information. store at 20° to 25°C (68° to 77°F)
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 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 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 Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 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 If pregnant or breast-feeding, ask a health professional before use.
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredient (in each tablet) *Esomeprazole 20 mg (Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ESOMEPRAZOLE MAGNESIUM. 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 |
|---|---|---|---|---|
| 59651-440-39 | 59651-440 | Aurobindo Pharma Limited | 3000 TABLET, DELAYED RELEASE in 1 BAG (59651-440-39) | July 12, 2023 |
| 58602-840-05 | 58602-840 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-840-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | July 12, 2023 |
| 58602-840-61 | 58602-840 | Aurohealth LLC | 2 BOTTLE in 1 CARTON (58602-840-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | July 12, 2023 |
| 58602-840-62 | 58602-840 | Aurohealth LLC | 3 BOTTLE in 1 CARTON (58602-840-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | July 12, 2023 |
| 51316-563-14 | 51316-563 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (51316-563-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | August 30, 2025 |
| 51316-563-42 | 51316-563 | CVS Pharmacy | 3 BOTTLE in 1 CARTON (51316-563-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | August 30, 2025 |
| 51316-088-01 | 51316-088 | CVS Pharmacy, Inc. | 1 BOTTLE in 1 CARTON (51316-088-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | July 4, 2024 |
| 51316-088-05 | 51316-088 | CVS Pharmacy, Inc. | 3 BOTTLE in 1 CARTON (51316-088-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | July 4, 2024 |
| 70000-0695-1 | 70000-0695 | Cardinal Health | 1 BOTTLE in 1 CARTON (70000-0695-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 27, 2024 |
| 70000-0695-2 | 70000-0695 | Cardinal Health | 3 BOTTLE in 1 CARTON (70000-0695-2) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 27, 2024 |
| 43598-069-42 | 43598-069 | Dr. Reddys Laboratories Inc | 3 BOTTLE in 1 CARTON (43598-069-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | December 30, 2023 |
| 75907-119-24 | 75907-119 | Dr. Reddys Laboratories Inc | 2400 TABLET, DELAYED RELEASE in 1 POUCH (75907-119-24) | November 1, 2023 |
| 75907-119-27 | 75907-119 | Dr. Reddys Laboratories Inc | 2 BOTTLE in 1 CARTON (75907-119-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | December 30, 2023 |
| 75907-119-33 | 75907-119 | Dr. Reddys Laboratories Inc | 3 BOTTLE in 1 CARTON (75907-119-33) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | December 30, 2023 |
| 75907-119-52 | 75907-119 | Dr. Reddys Laboratories Inc | 1 BOTTLE in 1 CARTON (75907-119-52) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | December 30, 2023 |
| 0363-0361-42 | 0363-0361 | WALGREEN CO. | 3 BOTTLE in 1 CARTON (0363-0361-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | July 8, 2024 |
| 0363-1353-14 | 0363-1353 | Walgreens | 1 BOTTLE in 1 CARTON (0363-1353-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 20, 2025 |
| 0363-1353-42 | 0363-1353 | Walgreens | 3 BOTTLE in 1 CARTON (0363-1353-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 20, 2025 |
| 59651-440 | 59651-440 | Aurobindo Pharma Limited | — | July 12, 2023 |
| 58602-840 | 58602-840 | Aurohealth LLC | — | July 12, 2023 |
| 51316-563 | 51316-563 | CVS Pharmacy | — | August 30, 2025 |
| 51316-088 | 51316-088 | CVS Pharmacy, Inc. | — | July 4, 2024 |
| 70000-0695 | 70000-0695 | Cardinal Health | — | June 27, 2024 |
| 43598-069 | 43598-069 | Dr. Reddys Laboratories Inc | — | December 30, 2023 |
| 75907-119 | 75907-119 | Dr. Reddys Laboratories Inc | — | November 1, 2023 |
| 0363-0361 | 0363-0361 | WALGREEN CO. | — | July 8, 2024 |
| 0363-1353 | 0363-1353 | Walgreens | — | June 20, 2025 |
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.