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Nexium 24HR

esomeprazole magnesium · Capsule, Delayed Release

Over-the-counter NDA RLD 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
Nexium 24HR
Generic name
esomeprazole magnesium
Dosage form
Capsule, Delayed Release
Route
Oral
Marketing category
NDA · NDA
Labeler
A-S Medication Solutions
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
7
Data completeness
76% 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

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Delayed Release
Route of administration
Oral
Presentations
9

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
204655
Application type
NDA · New Drug Application
Approval date
March 28, 2014
Sponsor
ASTRAZENECA LP
Products on application
1
Submissions recorded
11
Products approved under application 204655.
Product Trade name Form Strength Ingredient Status TE Flags
204655-001 NEXIUM 24HR CAPSULE, DELAYED RELEASE ESOMEPRAZOLE MAGNESIUM Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 204655.
Type No. Action Status Date Review
Supplement 18 Labeling Approved September 6, 2022 Standard
Supplement 14 Labeling Approved December 4, 2020 Standard
Supplement 11 Labeling Approved April 4, 2019 Standard
Supplement 9 Labeling Approved January 24, 2018 Standard
Supplement 7 Labeling Approved February 3, 2017 Standard
Supplement 6 Labeling Approved January 9, 2017 Standard
Supplement 4 Manufacturing (CMC) Approved June 17, 2016 Standard
Supplement 3 Manufacturing (CMC) Approved June 23, 2015 Standard
Supplement 2 Labeling Approved June 2, 2015 Standard
Supplement 1 Labeling Approved October 3, 2014 Standard
Original application 1 Type 8 - Partial Rx to OTC Switch Approved March 28, 2014 Standard

Review documents

  • 0 · Supplement · September 9, 2022
  • 0 · Supplement · September 7, 2022
  • 0 · Supplement · December 8, 2020
  • 0 · Supplement · April 8, 2019
  • 0 · Supplement · April 8, 2019
  • 0 · Supplement · February 6, 2018
  • 0 · Supplement · January 26, 2018
  • 0 · Supplement · February 6, 2017
  • 0 · Supplement · February 6, 2017
  • 0 · Supplement · January 24, 2017
  • 0 · Supplement · January 17, 2017
  • 0 · Supplement · June 3, 2015
  • 0 · Original application · December 9, 2014
  • 0 · Original application · December 9, 2014
  • 0 · Supplement · October 6, 2014
  • 0 · Supplement · October 6, 2014
  • 0 · Original application · April 2, 2014
  • 0 · Original application · March 31, 2014

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240514). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240514

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

openFDA Drug Labeling

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 Repeated 14-Day Courses (if needed) 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 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 Labeling

Warnings Allergy alert: Do not use if you are allergic to esomeprazole Esomeprazole may cause severe skin reactions. Symptoms include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical attention 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 If pregnant or breast-feeding, 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 right away.

Do Not Use

openFDA Drug Labeling

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

openFDA Drug Labeling

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 22.3 mg esomeprazole magnesium trihydrate) Purpose Acid reducer

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-1492 NDC: 50090-1492-0 14 CAPSULE, DELAYED RELEASE in a BOTTLE / 3 in a CARTON

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
50090-1492-0 50090-1492 A-S Medication Solutions 3 BOTTLE in 1 CARTON (50090-1492-0) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE December 4, 2014
0573-2450-02 0573-2450 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0573-2450-02) / 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK October 31, 2014
0573-2450-14 0573-2450 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-2450-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE May 27, 2014
0573-2450-28 0573-2450 Haleon US Holdings LLC 2 BOTTLE in 1 CARTON (0573-2450-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE May 27, 2014
0573-2450-42 0573-2450 Haleon US Holdings LLC 3 BOTTLE in 1 CARTON (0573-2450-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE May 27, 2014
0573-2450-43 0573-2450 Haleon US Holdings LLC 3 BOTTLE in 1 BLISTER PACK (0573-2450-43) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE May 27, 2014
0573-2450-44 0573-2450 Haleon US Holdings LLC 3 BOTTLE in 1 CARTON (0573-2450-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE May 27, 2014
50090-1492 50090-1492 A-S Medication Solutions — May 27, 2014
0573-2450 0573-2450 Haleon US Holdings LLC — May 27, 2014

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.