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Esomeprazole Magnesium

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
Capsule
Route
—
Marketing category
DRUG FOR FURTHER PROCESSING · BULK API
Labeler
Catalent Pharma Solutions, LLC
Product type
Drug For Further Processing
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
7
Packages
11
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 Trihydrate 20 mg/1 692576 View
Esomeprazole Magnesium Trihydrate 40 mg/1 692576 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
—
Presentations
18

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
212507
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 2, 2020
Sponsor
HETERO LABS LTD III
Products on application
1
Submissions recorded
1
Products approved under application 212507.
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
Most recent submissions on application 212507.
Type No. Action Status Date Review
Original application 1 Approved June 2, 2020 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260210 HUMAN OTC DRUG · 20250130

Indications and Usage

openFDA Drug Labeling

Use(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 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 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 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 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 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

Active Ingredient

openFDA Drug Labeling

Active 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 FAERS
235,236
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 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
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
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

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.