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NEXIUM

Esomeprazole magnesium · Capsule, Delayed Release

Prescription NDA TE AB RLD
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
Generic name
Esomeprazole magnesium
Dosage form
Capsule, Delayed Release
Route
Oral
Marketing category
NDA · NDA
Labeler
AstraZeneca Pharmaceuticals LP
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
54% 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 Trihydrate 20 mg/1 692576 View
Esomeprazole Magnesium Trihydrate 40 mg/1 692576 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Delayed Release
Route of administration
Oral
Presentations
6

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
021153
Application type
NDA · New Drug Application
Approval date
February 20, 2001
Sponsor
ASTRAZENECA
Products on application
2
Submissions recorded
42
Products approved under application 021153.
Product Trade name Form Strength Ingredient Status TE Flags
021153-001 NEXIUM CAPSULE, DELAYED REL PELLETS ESOMEPRAZOLE MAGNESIUM Prescription AB RLD
021153-002 NEXIUM CAPSULE, DELAYED REL PELLETS ESOMEPRAZOLE MAGNESIUM Prescription AB RLD RS

Therapeutic equivalence

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

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

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 021153.
Type No. Action Status Date Review
Supplement 60 Labeling Approved July 18, 2023 Standard
Supplement 59 Labeling Approved March 4, 2022 Standard
Supplement 56 Labeling Approved August 25, 2021 Standard
Supplement 57 Labeling Approved November 27, 2020 Standard
Supplement 53 Labeling Approved June 7, 2018 Standard
Supplement 51 Labeling Approved December 20, 2016 Standard
Supplement 52 Labeling Approved October 24, 2016 Standard
Supplement 50 Labeling Approved December 19, 2014 901 Required
Supplement 46 Labeling Approved March 27, 2014 Standard
Supplement 49 Labeling Approved February 25, 2014 901 Required
Supplement 48 Manufacturing (CMC) Approved February 14, 2014 —
Supplement 47 Manufacturing (CMC) Approved October 4, 2013 —
Supplement 45 Manufacturing (CMC) Approved June 17, 2013 —
Supplement 44 Labeling Approved November 28, 2012 Standard
Supplement 42 Labeling Approved October 9, 2012 Standard
Supplement 43 Labeling Approved September 28, 2012 Standard
Supplement 40 Labeling Approved January 20, 2012 Standard
Supplement 38 Labeling Approved June 30, 2011 Unknown
Supplement 35 Labeling Approved June 21, 2011 Unknown
Supplement 36 Labeling Approved September 3, 2010 Unknown
Supplement 34 Labeling Approved March 4, 2010 Unknown
Supplement 33 Labeling Approved October 9, 2009 Standard
Supplement 31 Labeling Approved January 15, 2009 Standard
Supplement 29 Labeling Approved January 11, 2008 Standard
Supplement 28 Labeling Approved April 27, 2007 —
Supplement 27 Labeling Approved April 27, 2007 Standard
Supplement 23 Efficacy Approved October 11, 2006 Unknown
Supplement 25 Labeling Approved September 26, 2006 Standard
Supplement 24 Labeling Approved September 15, 2006 Standard
Supplement 22 Efficacy Approved April 28, 2006 Priority
Supplement 21 Labeling Approved February 16, 2006 Standard
Supplement 20 Labeling Approved June 6, 2005 Standard
Supplement 19 Efficacy Approved November 24, 2004 Unknown
Supplement 15 Labeling Approved April 23, 2004 Standard
Supplement 8 Labeling Approved January 9, 2004 Standard
Supplement 4 Labeling Approved February 27, 2003 Standard
Supplement 6 Manufacturing (CMC) Approved October 1, 2002 —
Supplement 5 Labeling Approved September 20, 2002 Standard
Supplement 3 Manufacturing (CMC) Approved March 14, 2002 —
Supplement 2 Manufacturing (CMC) Approved May 16, 2001 —
Supplement 1 Manufacturing (CMC) Approved May 16, 2001 —
Original application 1 Type 2 - New Active Ingredient Approved February 20, 2001 Priority

Review documents

  • 0 · Supplement · July 20, 2023
  • 0 · Supplement · July 20, 2023
  • 0 · Supplement · July 19, 2023
  • 0 · Supplement · March 10, 2022
  • 0 · Supplement · March 7, 2022
  • 0 · Supplement · August 31, 2021
  • 0 · Supplement · August 27, 2021
  • 0 · Supplement · November 30, 2020
  • 0 · Supplement · November 30, 2020
  • 0 · Supplement · June 14, 2018
  • 0 · Supplement · June 11, 2018
  • 0 · Supplement · December 22, 2016
  • 0 · Supplement · December 21, 2016
  • 0 · Supplement · October 28, 2016
  • 0 · Supplement · October 26, 2016
  • 0 · Supplement · December 29, 2014
  • 0 · Supplement · December 24, 2014
  • 0 · Supplement · August 5, 2014
  • 0 · Supplement · August 5, 2014
  • 0 · Supplement · August 5, 2014
  • 0 · Supplement · April 1, 2014
  • 0 · Supplement · March 28, 2014
  • 0 · Supplement · March 5, 2014
  • 0 · Supplement · February 27, 2014
  • 0 · Supplement · December 10, 2012
  • 0 · Supplement · November 29, 2012
  • 0 · Supplement · October 12, 2012
  • 0 · Supplement · October 12, 2012
  • 0 · Supplement · October 11, 2012
  • 0 · Supplement · October 2, 2012

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
0186-5020-31 0186-5020 AstraZeneca Pharmaceuticals LP 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-31) March 19, 2001
0186-5020-54 0186-5020 AstraZeneca Pharmaceuticals LP 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-54) March 19, 2001
0186-5040-31 0186-5040 AstraZeneca Pharmaceuticals LP 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-31) March 19, 2001
0186-5040-54 0186-5040 AstraZeneca Pharmaceuticals LP 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-54) March 19, 2001
0186-5020 0186-5020 AstraZeneca Pharmaceuticals LP — March 19, 2001
0186-5040 0186-5040 AstraZeneca Pharmaceuticals LP — March 19, 2001

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
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.