Quick answers
- What is Esomeprazole used for?
- The FDA-approved label (Nexium, AstraZeneca Pharmaceuticals LP, December 19, 2025) says: “NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. • Maintenance of healing of EE in adults. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Esomeprazole have a boxed warning?
- No. None of the 87 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Esomeprazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Esomeprazole been recalled?
- FDA enforcement reports list 11 recalls of products of this medicine; the newest started May 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Esomeprazole?
- 43 companies list prescription products of Esomeprazole in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Aurobindo Pharma Limited.
What Esomeprazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. • Maintenance of healing of EE in adults. …
— FDA label: Nexium, AstraZeneca Pharmaceuticals LP, effective December 19, 2025. Read the full label on DailyMed →
The FDA has 87 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 87 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, delayed release · Granule, delayed release · Capsule, delayed release pellets · Capsule, coated pellets · For suspension · Injection, powder, lyophilized, for solution · Injection · Granule, for suspension, extended release |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 129 in the FDA NDC Directory |
| Brand names | Nexium |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| esomeprazole magnesium 10 mg granule, delayed release | Generic | $4.65 per unit |
| esomeprazole magnesium 10 mg granule, for suspension, extended release | Generic | $4.65 per unit |
| esomeprazole magnesium 2.5 mg granule, delayed release | Generic | $5.31 per unit |
| esomeprazole magnesium 20 mg capsule, coated pellets | Generic | $0.1397 per capsule |
| esomeprazole magnesium 20 mg capsule, delayed release | Generic | $0.1397 per capsule |
| esomeprazole magnesium 20 mg capsule, delayed release pellets | Generic | $0.1397 per capsule |
| esomeprazole magnesium 20 mg granule, delayed release | Generic | $3.62 per unit |
| esomeprazole magnesium 40 mg capsule, coated pellets | Generic | $0.1279 per capsule |
| esomeprazole magnesium 40 mg capsule, delayed release | Generic | $0.1279 per capsule |
| esomeprazole magnesium 40 mg capsule, delayed release pellets | Generic | $0.1279 per capsule |
| esomeprazole magnesium 40 mg granule, delayed release | Generic | $4.37 per unit |
| esomeprazole magnesium 5 mg granule, delayed release | Generic | $4.59 per unit |
| esomeprazole magnesium dihydrate 2.5 mg for suspension | Generic | $5.31 per unit |
| esomeprazole magnesium dihydrate 20 mg capsule, delayed release | Generic | $0.1397 per capsule |
| esomeprazole magnesium dihydrate 20 mg for suspension | Generic | $3.62 per unit |
| esomeprazole magnesium dihydrate 20 mg granule, delayed release | Generic | $3.62 per unit |
| esomeprazole magnesium dihydrate 40 mg capsule, delayed release | Generic | $0.1279 per capsule |
| esomeprazole magnesium dihydrate 40 mg for suspension | Generic | $4.37 per unit |
| esomeprazole magnesium dihydrate 40 mg granule, delayed release | Generic | $4.37 per unit |
| esomeprazole magnesium dihydrate 5 mg for suspension | Generic | $4.59 per unit |
| esomeprazole magnesium trihydrate 10 mg granule, delayed release | Generic | $4.65 per unit |
| esomeprazole magnesium trihydrate 10 mg granule, delayed release | Brand: Nexium | $9.14 per unit |
| esomeprazole magnesium trihydrate 2.5 mg granule, delayed release | Brand: Nexium | $9.16 per unit |
| esomeprazole magnesium trihydrate 20 mg capsule, delayed release | Generic | $0.1397 per capsule |
| esomeprazole magnesium trihydrate 20 mg capsule, delayed release | Brand: Nexium | $8.77 per capsule |
| esomeprazole magnesium trihydrate 20 mg granule, delayed release | Generic | $3.62 per unit |
| esomeprazole magnesium trihydrate 20 mg granule, delayed release | Brand: Nexium | $9.14 per unit |
| esomeprazole magnesium trihydrate 40 mg capsule, delayed release | Generic | $0.1279 per capsule |
| esomeprazole magnesium trihydrate 40 mg capsule, delayed release | Brand: Nexium | $8.78 per capsule |
| esomeprazole magnesium trihydrate 40 mg granule, delayed release | Generic | $4.37 per unit |
| esomeprazole magnesium trihydrate 40 mg granule, delayed release | Brand: Nexium | $9.12 per unit |
| esomeprazole magnesium trihydrate 5 mg granule, delayed release | Generic | $4.59 per unit |
| esomeprazole magnesium trihydrate 5 mg granule, delayed release | Brand: Nexium | $9.15 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack12 products
- A-S Medication Solutions11 products
- Aurobindo Pharma Limited8 products
- AstraZeneca Pharmaceuticals LP7 products
- Torrent Pharmaceuticals Limited5 products
- Cipla USA Inc.5 products
- Proficient Rx LP4 products
- Ascend Laboratories, LLC4 products
- Asclemed USA, Inc.4 products
- Preferred Pharmaceuticals Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Zydus Lifesciences Limited4 products
- NuCare Pharmaceuticals, Inc.3 products
- Remedyrepack Inc.3 products
- Advanced Rx of Tennessee, LLC3 products
- Quallent Pharmaceuticals Health LLC2 products
- NorthStar Rx LLC2 products
- Dr. Reddy's Laboratories Inc.2 products
- Golden State Medical Supply, Inc.2 products
- Somerset Therapeutics, LLC2 products
- Rising Pharma Holdings, Inc.2 products
- Lannett Company, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Direct_Rx2 products
- Biocon Pharma Inc.2 products
- Granules Pharmaceuticals Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Zhejiang Yongtai Pharmaceutical Co., Ltd2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Solco Healthcare US, LLC2 products
- Gland Pharma Limited2 products
- Macleods Pharmaceuticals Limited2 products
- R2 Pharma, LLC2 products
- Medsource Pharmaceuticals1 product
- AvPAK1 product
- American Health Packaging1 product
- St. Mary's Medical Park Pharmacy1 product
- Major Pharmaceuticals1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- Slate Run Pharmaceuticals, LLC1 product
- Eugia US LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021153 NEXIUM | Astrazeneca | February 20, 2001 | 41, latest July 18, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
| NDA021957 NEXIUM | Astrazeneca | October 20, 2006 | 22, latest July 18, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
| NDA022101 NEXIUM | Astrazeneca | February 27, 2008 | 20, latest July 18, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
| NDA202342 ESOMEPRAZOLE STRONTIUM | Belcher | August 6, 2013 | 5, latest March 4, 2022 2022: Labeling · 2020: Labeling · 2018: Labeling |
Generic approvals (28)
- ANDA078936Mylan · August 3, 2015
- ANDA078279DR Reddys · September 25, 2015
- ANDA205606Aurobindo Pharma Ltd · April 21, 2016
- ANDA204657Eugia Pharma · August 10, 2016
- ANDA205563Lannett Co Inc · September 1, 2017
- ANDA208333Alkem Labs Ltd · October 20, 2017
- ANDA209735Sun Pharm · April 30, 2018
- ANDA209495Glenmark Speclt · May 10, 2019
- ANDA206296Zydus Pharms · May 22, 2019
- ANDA211751Cipla · March 23, 2020
- ANDA211752Cipla · March 23, 2020
- ANDA203349Gland · April 1, 2020
- ANDA211977Hetero Labs Ltd III · June 2, 2020
- ANDA212949Cspc Ouyi · October 2, 2020
- ANDA213859Guangzhou Novaken · November 18, 2020
- ANDA210559Indchemie Health · February 26, 2021
- ANDA213486Graviti Pharms · March 19, 2021
- ANDA215732Hainan Poly · February 10, 2022
- ANDA214920Prinston Inc · March 28, 2023
- ANDA206055Zydus Pharms · June 7, 2023
- ANDA217427Granules · October 18, 2023
- ANDA217022Zhejiang Yongtai · December 27, 2023
- ANDA208511Macleods Pharms · October 23, 2024
- ANDA217714Cipla · January 7, 2025
- ANDA212651Torrent · March 5, 2025
- ANDA212652Torrent · March 5, 2025
- ANDA218948Aurobindo Pharma Ltd · April 15, 2025
- ANDA219213Aurobindo Pharma Ltd · April 15, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 13, 2025 · Class II · Ongoing · D-0442-2025
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) — Zydus Pharmaceuticals (USA) Inc
-
May 13, 2025 · Class II · Ongoing · D-0443-2025
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) — Zydus Pharmaceuticals (USA) Inc
-
November 14, 2024 · Class III · Ongoing · D-0102-2025
Labeling: Not Elsewhere Classified - Wrong NDC number
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, — Zydus Pharmaceuticals (USA) Inc
-
June 21, 2022 · Class III · Terminated · D-0005-2023
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, N — SUN PHARMACEUTICAL INDUSTRIES INC
-
June 21, 2022 · Class III · Terminated · D-0004-2023
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ — SUN PHARMACEUTICAL INDUSTRIES INC
-
December 17, 2020 · Class II · Terminated · D-0183-2021
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 30 — CIPLA
-
December 17, 2020 · Class II · Terminated · D-0181-2021
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 30 — CIPLA
-
December 17, 2020 · Class II · Terminated · D-0182-2021
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 30 — CIPLA
-
April 24, 2020 · Class III · Terminated · D-1256-2020
Discoloration: product contains brown pellets
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10 — Dr. Reddy's Laboratories, Inc.
-
February 6, 2019 · Class III · Terminated · D-0995-2019
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA. — Dr. Reddy's Laboratories, Inc.
-
July 2, 2012 · Class III · Terminated · D-1410-2012
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC — ASTRA ZENECA Lp
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nexium, AstraZeneca Pharmaceuticals LP, effective December 19, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →