On this page

Esomeprazole Magnesium

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Esomeprazole Magnesium
Generic name
Esomeprazole Magnesium
Dosage form
Tablet, Delayed Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Dr. Reddys Laboratories Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
9
Packages
18
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Esomeprazole Magnesium 20 mg/1 606726 View
Esomeprazole Magnesium Dihydrate 20 mg/1 606726 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Delayed Release
Route of administration
Oral
Presentations
27

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Application number
214473
Application type
ANDA · Abbreviated New Drug Application
Approval date
July 12, 2023
Sponsor
AUROBINDO PHARMA LTD
Products on application
1
Submissions recorded
1
Products approved under application 214473.
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
Most recent submissions on application 214473.
Type No. Action Status Date Review
Original application 1 Approved July 12, 2023 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260212 HUMAN OTC DRUG · 20250830 HUMAN OTC DRUG · 20231214

Indications and Usage

openFDA Drug Labeling

Uses 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 Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions 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 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 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 Labeling

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

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 breast-feeding, ask a health professional before use.

Active Ingredient

openFDA Drug Labeling

Drug 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 FAERS
232,754
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
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

Every dataset that contributed a fact to 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.