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Esomeprazole Magnesium DR 20 mg Capsule, Delayed Release, 60-count — NDC 80425-0111-02 package photo

Esomeprazole Magnesium DR 20 mg Capsule, Delayed Release, 60-count

by Advanced Rx Pharmacy of Tennessee, LLC · 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0111-2)
NDC 80425-0111-02
🏷️ FDA NDC (as labeled) 80425-0111-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.3386/unit — full pricing hub ↓
Also comes in: 30 capsules 80425-0111-01
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Esomeprazole Magnesium (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 13, 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. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0443-2025
Class II · May 13, 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. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0442-2025
Class III · Nov 14, 2024 — Labeling: Not Elsewhere Classified - Wrong NDC number (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0102-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 80425-0111-2
Product NDC 80425-0111
11-digit billing NDC 80425011102
NCPDP billing unit EA — each (per item)
RxCUI 606726
UNII 36H71644EQ
Application # ANDA205606
SPL Set ID b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-21
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance ESOMEPRAZOLE MAGNESIUM DIHYDRATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0111-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0111-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors, Propionic acid derivatives
How it works Proton Pump Inhibitors, Cytochrome P450 2C19 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA205606 (ANDA)
Labeler code80425
First marketedApr 2016
Product typeHuman Prescription Drug
Portfolio254 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's blocking the 'acid pump' — a tiny enzyme in your stomach lining that releases acid. By shutting down that pump, esomeprazole cuts the amount of acid your stomach produces, giv...
  • What is esomeprazole actually doing in my body?
  • Before eating is best — ideally at least 30 minutes before your first meal of the day. Food can reduce how much of the medicine your body absorbs by nearly half, so timing really d...
  • Should I take it before or after eating?
📖 Read our full Esomeprazole guide →
9
Nutrient depletion considerations

Esomeprazole Magnesium may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Esomeprazole Magnesium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white
ShapeCapsule
ImprintI81
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3386 $20.32 / 60 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Esomeprazole Magnesium 20 mg 00378-2350-77 Mylan 90 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 16714-0979-01 NorthStar 30 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 31722-0664-10 Camber 1000 capsules $0.145 AB Availability likely —
Esomeprazole magnesium 20 mg 43547-0001-03 Solco 30 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 43598-0509-10 Dr. 1000 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 62175-0820-32 Lannett 30 capsules $0.145 AB Availability likely —
Esomeprazole magnesium 20 mg 63304-0734-10 Sun 1000 capsules $0.145 AB Availability likely —
Esomeprazole magnesium 20 mg 64980-0632-03 Rising 30 capsules $0.145 AB Availability likely —
esomeprazole magnesium 20 mg 68382-0441-06 Zydus 30 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 70069-0814-10 Somerset 1000 capsules $0.145 AB Availability likely —
esomeprazole magnesium 20 mg 70377-0055-11 Biocon 30 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 82009-0033-10 Quallent 1000 capsules $0.145 AB Availability likely —
Esomeprazole Magnesium 20 mg 68462-0390-10 Glenmark 1000 capsules $0.177 — FDA listed —
Esomeprazole 20 mg 51660-0027-14 Ohm 14 capsules $0.343 — FDA listed —
Good Sense Esomeprazole Magnesium 20 mg 00113-0898-01 L. 14 capsules $0.346 — Availability likely —
Esomeprazole Magnesium 20 mg 16571-0880-41 Rising 14 capsules $0.346 — Availability likely —
Good Neighbor Pharmacy Esomeprazole Magnesium 20 mg 46122-0641-04 Amerisource 14 capsules $0.346 — Availability likely —
Esomeprazole Magnesium 20 mg 46122-0736-03 Amerisource 14 capsules $0.346 — Availability likely —
Esomeprazole Magnesium 20 mg 69230-0320-31 Camber 14 capsules $0.346 — Availability likely —
leader esomeprazole magnesium 20 mg 70000-0727-01 Cardinal 14 capsules $0.346 — Availability likely —
Esomeprazole Magnesium 20 mg 70000-0731-01 LEADER/ 14 capsules $0.346 — Availability likely —
Foster and Thrive Acid Reducer 20 mg 70677-1099-01 Strategic 14 capsules $0.346 — Availability likely —
Esomeprazole Magnesium 20 mg 43598-0407-27 Dr. 14 capsules $0.349 — Availability likely —
Esomeprazole Magnesium 20 mg 63868-0425-14 CHAIN 14 capsules $0.361 — FDA listed —
Nexium 20 mg 00186-5020-31 AstraZeneca 30 capsules $8.777 AB Availability likely —
good sense esomeprazole magnesium 20 mg 00113-0651-01 L. 14 capsules — — Discontinued —
good sense esomeprazole magnesium 20 mg 00113-2022-02 L. 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 00363-0508-05 WALGREEN 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 00363-0772-14 WALGREENS 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 00363-1699-01 Walgreen 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 00363-3298-01 Walgreens 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 00363-7223-01 Walgreen 14 capsules — — FDA listed —
Esomeprazole Magnesium Delayed Release 20 mg 00363-7810-41 WALGREENS 14 capsules — — FDA listed —
Nexium 24HR 20 mg 00573-2450-02 Haleon 2 capsules — — FDA listed —
Nexium 24HR ClearMinis 20 mg 00573-2452-02 Haleon 2 capsules — — FDA listed —
Up and Up Esomeprazole Magnesium 20 mg 11673-0753-01 Target 14 capsules — — FDA listed —
up and up esomeprazole magnesium 20 mg 11673-0898-01 Target 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 11822-0024-05 Rite 1 capsule — — FDA listed —
esomeprazole magnesium 20 mg 11822-0898-01 Rite 14 capsules — — Discontinued —
signature care esomeprazole magnesium 20 mg 21130-0088-01 Safeway 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 21130-0100-05 Better 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 21130-0257-41 BETTER 14 capsules — — FDA listed —
signature care esomeprazole magnesium 20 mg 21130-0714-01 Safeway 14 capsules — — Discontinued —
Esomeprazole magnesium 20 mg 21130-0718-41 BETTER 14 capsules — — FDA listed —
Esomeprazole 20 mg 21130-0926-14 Safeway, 14 capsules — — FDA listed —
Esomeprazole Magnesium Delayed-Release Capsules, 20 mg 25000-0075-76 MARKSANS 14 capsules — — FDA listed —
Esomeprazole Magnesium Delayed-Release 20 mg (OTC) 25000-0088-76 MARKSANS 14 capsules — — FDA listed —
Esomeprazole Magnesium Delayed Release 20 mg mini 25000-0096-76 MARKSANS 14 capsules — — FDA listed —
Esomeprazole Magnesium Delayed-Release 20 mg mini 25000-0112-76 MARKSANS 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 30142-0261-14 The 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 30142-0273-01 Kroger 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 30142-0528-14 KROGER 14 capsules — — FDA listed —
esomeprazole 20 mg 30142-0989-28 THE 14 capsules — — FDA listed —
esomeprazole 20 mg 33342-0306-07 Macleods 30 capsules — — FDA listed —
topcare esomeprazole magnesium 20 mg 36800-0627-01 Topco 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 37808-0115-14 HEB 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 37808-0364-14 H 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 37808-0719-01 H 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 41250-0727-01 Meijer 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 41250-0900-01 Meijer 14 capsules — — FDA listed —
careone esomeprazole magnesium 20 mg 41520-0727-01 American 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 42507-0774-42 HyVee 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 42507-0898-42 HyVee 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 43598-0067-42 Dr. 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 43598-0327-27 Dr. 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 43598-0812-14 Dr. 14 capsules — — Discontinued —
Esomeprazole Magnesium 20 mg 43598-0926-28 Dr. 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 45865-0163-30 Medsource 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 46122-0821-59 Amerisource 14 capsules — — FDA listed —
equate esomeprazole magnesium 20 mg 49035-0921-14 Wal-Mart 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 49035-0980-05 Wal-Mart 14 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 49483-0718-41 TIME 14 capsules — — FDA listed —
Nexium 24HR 20 mg 50090-1492-00 A-S 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 50090-6198-00 A-S 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 50090-6213-00 A-S 30 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 51316-0220-01 CVS 14 capsules — — FDA listed —
Esomeprazole 20 mg 51316-0715-14 CVS 14 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 51407-0742-10 Golden 1000 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 53041-0666-07 Guardian 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 53943-0039-14 DISCOUNT 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 53943-0527-14 Discount 14 capsules — — FDA listed —
Exchange Select Esomeprazole Magnesium 20 mg 55301-0898-01 Army 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 55319-0051-03 Family 14 capsules — — FDA listed —
dg health esomeprazole magnesium 20 mg 55910-0250-01 Dolgencorp, 14 capsules — — FDA listed —
DG Health Esomeprazole Magnesium 20 mg 55910-0593-01 Dolgencorp 14 capsules — — FDA listed —
dg health esomeprazole magnesium 20 mg 55910-0640-01 Dolgencorp 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 56062-0020-06 Publix 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 56062-0898-01 Publix 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 57483-0225-42 INNOVUS 14 capsules — — FDA listed —
Esomeprazole 20 mg 57483-0900-42 INNOVUS 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 58602-0707-05 Aurohealth 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 58602-0809-05 Aurohealth 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 58602-0822-05 Aurohealth 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 58602-0846-05 Aurohealth 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 58602-0896-62 Aurohealth 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 59651-0561-50 Aurobindo 50000 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 60000-0109-03 Ahold 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 60687-0934-21 American 1 capsule — AB FDA listed —
Esomeprazole Magnesium 20 mg 63187-0964-30 Proficient 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 63941-0971-03 Best 14 capsules — — FDA listed —
Esomeprazole 20 mg 63941-0999-14 VALU 14 capsules — — FDA listed —
kirkland signature esomeprazole magnesium 20 mg 63981-0898-03 Costco 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 64980-0664-19 Rising 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 65862-0783-01 Aurobindo 100 capsules — AB FDA listed —
Esomeprazole magnesium 20 mg 67877-0478-05 Ascend 500 capsules — AB FDA listed —
Esomeprazole magnesium 20 mg 67877-0571-05 Ascend 500 capsules — AB FDA listed —
esomeprazole magnesium 20 mg 68071-3419-06 NuCare 60 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 68071-3735-03 NuCare 30 capsules — AB FDA listed —
members mark esomeprazole magnesium 20 mg 68196-0898-03 Sam's 14 capsules — — FDA listed —
berkley and jensen heartburn treatment 20 mg 68391-0898-03 BJWC 14 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 68788-4014-09 Preferred 90 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 68788-8511-01 Preferred 100 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 69168-0472-14 Allegiant 14 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 69434-0012-01 Zhejiang 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 69618-0073-42 Reliable 14 capsules — — FDA listed —
Riopan 20 mg 69729-0791-14 OPMX 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 69842-0248-06 CVS 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 69842-0703-01 CVS 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 69842-0898-01 CVS 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 69844-0115-01 Graviti 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 70000-0738-01 LEADER/ 14 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 70010-0133-03 Granules 30 capsules — AB FDA listed —
esomeprazole magnesium 20 mg 70771-1493-00 Zydus 1000 capsules — AB FDA listed —
Esomeprazole magnesium 20 mg 71205-0706-30 Proficient 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 71335-0807-01 Bryant 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 71335-1170-01 Bryant 30 capsules — AB FDA listed —
esomeprazole magnesium 20 mg 71335-1368-01 Bryant 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 71335-2018-01 Bryant 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 71335-2505-01 Bryant 30 capsules — AB FDA listed —
Esomeprazole magnesium 20 mg 71335-9678-01 Bryant 30 capsules — AB FDA listed —
esomeprazole magnesium 20 mg 71335-9713-01 Bryant 30 capsules — AB FDA listed —
Esomeprazole DR 20 mg 72189-0381-30 Direct_Rx 30 capsules — AB FDA listed —
Basic Care Esomeprazole Magnesium 20 mg 72288-0560-01 Amazon.com 14 capsules — — FDA listed —
basic care esomeprazole magnesium 20 mg 72288-0700-03 Amazon.com 14 capsules — — FDA listed —
basic care esomeprazole magnesium 20 mg 72288-0898-01 Amazon.com 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 72476-0500-03 Retail 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 72559-0011-06 LITTLE 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 72657-0124-42 GLENMARK 14 capsules — — FDA listed —
esomeprazole magnesium 20 mg 72657-0127-42 GLENMARK 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 72789-0352-30 PD-Rx 30 capsules — AB FDA listed —
Esomeprazole 20 mg 73581-0013-42 YYBA 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 73581-0014-42 YYBA 42 capsules — — FDA listed —
Esomeprazole magnesium 20 mg 76420-0226-30 Asclemed 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 76420-0904-00 Asclemed 1000 capsules — AB FDA listed —
esomeprazole magnesium 20 mg 79481-0411-00 Meijer, 14 capsules — — FDA listed —
equate esomeprazole magnesium 20 mg 79903-0293-42 WALMART 14 capsules — — FDA listed —
Esomeprazole Magnesium 20 mg 79903-0382-42 Walmart 14 capsules — — FDA listed —
Equate Esomeprazole Magnesium 20 mg 79903-0419-42 WALMART 14 capsules — — FDA listed —
Esomeprazole Magnesium DR 20 mgthis 80425-0111-02 Advanced 60 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 80425-0419-01 Advanced 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 80425-0420-01 Advanced 30 capsules — AB FDA listed —
Esomeprazole Magnesium 20 mg 83324-0200-14 CHAIN 14 capsules — — FDA listed —
24 HOUR Esomeprazole Magnesium 20 mg 85828-0718-45 Grocery 14 capsules — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2016
On the market since
Apr 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Esomeprazole Magnesium (matched by generic name) — the program that covers self-administered drugs. 18 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Esomeprazole Magnesium. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$26.52M
Claims incl. refills
740.1K
Beneficiaries
544.7K
Spend / beneficiary
$48.68
Spend / claim
$35.83
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Esomeprazole Magnesium — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease35,579
Acute Kidney Injury20,434
Renal Failure16,275
Nausea13,462
Gastrooesophageal Reflux Disease11,987
Diarrhoea11,156
Pain10,677

Age at onset

Neonate89
Infant56
Child178
Adolescent222
Adult11,409
Elderly10,846

Reporter sex

232,751 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization71,884
Life-threatening8,925
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 8,260 3,530
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80425-0111-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0111-1) 2016-04-21 Active
80425-0111-02 You're viewing this 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0111-2) 2016-04-21 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 80425-0111-02?
NDC 80425-0111-02 is a 60-count package — 60 capsule, delayed release in 1 bottle.
What is the difference between NDC 80425-0111-02 and NDC 80425-0111-01?
Both are Esomeprazole Magnesium DR 20 mg Capsule, Delayed Release — the drug itself is identical. NDC 80425-0111-02 is the 60-count package, while NDC 80425-0111-01 is the 30 capsules package.
What NDC number is used to bill for this package of Esomeprazole Magnesium DR 20 mg Capsule, Delayed Release?
Bill NDC 80425-0111-02 — the 11-digit billing format is 80425011102. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide
🎯 Indications and Usage ~2 min read ▾

1. Indications and Usage Section 1 INDICATIONS AND USAGE

1.1Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis.

Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.

1.2Risk Reduction of NSAID-Associated Gastric Ulcer Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

1.3H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy (esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin): Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see DOSAGE AND ADMINISTRATION (2) and CLINICAL STUDIES (14)].

In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see CLINICAL PHARMACOLOGY (12.4) and the prescribing information for clarithromycin].

1.4Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

⏱️ Dosage and Administration ~3 min read ▾

2. Dosage and Administration Section

2.1Recommended Dosage in Adults by Indication Table 1 shows the recommended adult dosage of esomeprazole magnesium delayed-release capsules by indication. The duration of esomeprazole magnesium delayed-release capsules treatment should be based on available safety and efficacy data specific to the defined indication and dosing frequency and individual patient medical needs. Esomeprazole magnesium delayed-release capsules should only be initiated and continued if the benefits outweigh the risks of treatment.

Table 1: Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules in Adults by Indication Adult Indication Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules Treatment Duration Healing of EE 20 mg or 40 mg1 once daily 4 to 8 weeks2 Maintenance of Healing of EE 20 mg once daily Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD 20 mg once daily 4 weeks; if symptoms do not resolve completely, consider an additional 4 weeks Risk Reduction of NSAID-Associated Gastric Ulcer 20 mg or 40 mg1 once daily Controlled studies do not extend beyond 6 months H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy) Esomeprazole magnesium delayed-release capsules 40 mg once daily1 Amoxicillin 1000 mg twice daily3 Clarithromycin 500 mg twice daily3 Starting dosage is 40 mg twice daily4; individualize the regimen to patient needs.

10 days 10 days 10 days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Dosages of up to 240 mg/day have been administered [see CLINICAL STUDIES (14.7)]. As long as clinically indicated 1. A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS (8.6)].

2. Most patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be required to achieve healing [see CLINICAL STUDIES (14.1)].

3. Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. 4.

A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see USE IN SPECIFIC POPULATIONS (8.6)].

2.2Recommended Dosage in Pediatric Patients by Indication Table 2 shows the recommended dosage of esomeprazole magnesium delayed-release capsules in pediatric patients by indication. Table 2: Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules in Pediatric Patients by Indication Indication Patient Age Recommended Dosage Duration Healing of EE 12 years to 17 years Esomeprazole magnesium delayed-release capsules: 20 mg or 40 mg once daily 4 to 8 Weeks Treatment of Symptomatic GERD 12 years to 17 years Esomeprazole magnesium delayed-release capsules: 20 mg once daily 4 weeks

2.3Preparation and Administration Instructions Take Esomeprazole magnesium delayed-release capsules at least one hour before meals [see CLINICAL PHARMACOLOGY (12.3)]. Antacids may be used concomitantly with esomeprazole magnesium delayed-release capsules. Take a missed dose as soon as possible.

If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time. Esomeprazole Magnesium Delayed-Release Capsules Administer esomeprazole magnesium delayed-release capsules orally or via a nasogastric tube, as described below.

Oral Administration Swallow esomeprazole magnesium delayed-release capsules whole; do not chew or crush the capsules. For patients who have difficulty swallowing capsules, esomeprazole magnesium delayed-release capsules can be opened, and the contents sprinkled on applesauce. Use with other foods has not been evaluated and is not recommended.

Add one tablespoon of applesauce to an empty bowl. The applesauce used should not be hot and should be soft…

💊 Dosage Forms and Strengths 73 words ▾

3. Dosage Forms and Strengths Esomeprazole magnesium delayed-release capsules USP 20 mg are white/white size ‘4’ hard gelatin capsules filled with white to off white spherical to oval pellets and imprinted with "I81" on body with gold tek ink. Esomeprazole magnesium delayed-release capsules USP 40 mg are white/white size ‘2’ hard gelatin capsules filled with white to off white spherical to oval pellets and imprinted with "I82" on body with gold tek ink.

⛔ Contraindications 72 words ▾

4. Contraindications Esomeprazole magnesium delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see WARNINGS AND PRECAUTIONS (5.2), ADVERSE REACTIONS (6)].

For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole magnesium delayed-release capsules, refer to the CONTRAINDICATIONS section of their package inserts.

⚠️ Warnings and Cautions ~3 min read ▾

5. Warnings and Precautions

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with esomeprazole magnesium delayed-release capsules do not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

5.2Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).

Discontinue esomeprazole magnesium delayed-release capsules and evaluate patients with suspected acute TIN [see CONTRAINDICATIONS (4)].

5.3Clostridium difficile-Associated Diarrhea Published observational studies suggest that PPI therapy like esomeprazole magnesium delayed-release capsules may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see ADVERSE REACTIONS (6.2)]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with esomeprazole magnesium delayed-release capsules, refer to Warnings and Precautions section of the corresponding prescribing information.

5.4Bone Fracture Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see DOSAGE AND ADMINISTRATION (2) and ADVERSE REACTIONS (6.2)].

5.5Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs.

PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving esomeprazole magnesium delayed-release capsules, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks.…

🤒 Adverse Reactions ~2 min read ▾

6. Adverse Reactions The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see WARNINGS AND PRECAUTIONS (5.2)] Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS (5.3)] Bone Fracture [see WARNINGS AND PRECAUTIONS (5.4)] Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS (5.5)] Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS (5.7)] Hypomagnesemia [see WARNINGS AND PRECAUTIONS (5.8)] Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS (5.12)]

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The safety of esomeprazole magnesium delayed-release capsules was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada.

Over 2,900 patients were treated in long-term studies for up to 6 to 12 months. In general, esomeprazole magnesium delayed-release capsules were well tolerated in both short and long-term clinical trials. The safety in the treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials, which included 1,240 patients on esomeprazole magnesium delayed-release capsules 20 mg, 2,434 patients on esomeprazole magnesium delayed-release capsules 40 mg, and 3,008 patients on omeprazole 20 mg daily.

The most frequently occurring adverse reactions (≥1%) in all three groups were headache (5.5, 5, and 3.8, respectively) and diarrhea (no difference among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking esomeprazole magnesium delayed-release capsules or omeprazole. Additional adverse reactions that were reported as possibly or probably related to esomeprazole magnesium delayed-release capsules with an incidence < 1% are listed below by body system: Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors; Cardiovascular: flushing, hypertension, tachycardia; Endocrine: goiter; Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting; Hearing: earache, tinnitus; Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia; Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased; Metabolic/Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease; Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica; Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect; Reproductive: dysmenorrhea, menstrual disorder, vaginitis; Respiratory: asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis; Skin and Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammat…

🔄 Drug Interactions ~2 min read ▾

7. Drug Interactions Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with esomeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Esomeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with esomeprazole may reduce antiviral effect and promote the development of drug resistance [se e CLINICAL PHARMACOLOGY (12.3)].

Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with esomeprazole may increase toxicity [see CLINICAL PHARMACOLOGY (12.3)]. There are other antiretroviral drugs which do not result in clinically relevant interactions with esomeprazole. Intervention: Rilpivirine-containing products: Concomitant use with esomeprazole magnesium delayed-release capsules are contraindicated [see CONTRAINDICATIONS (4)].

Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with esomeprazole magnesium delayed-release capsules. See prescribing information for nelfinavir.

Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals: See prescribing information for specific antiretroviral drugs Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including esomeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.

Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain the target INR range. Methotrexate Clinical Impact: Concomitant use of esomeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see WARNINGS AND PRECAUTIONS (5.11)].

Intervention: A temporary withdrawal of esomeprazole magnesium delayed-release capsules may be considered in some patients receiving high-dose methotrexate. 2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol) Clopidogrel Clinical Impact: Concomitant use of esomeprazole 40 mg resulted in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see CLINICAL PHARMACOLOGY (12.3)]. There are no adequate combination studies of a lower dose of esomeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel.

Intervention: Avoid concomitant use with esomeprazole magnesium delayed-release capsules Consider use of alternative anti-platelet therapy [see WARNINGS AND PRECAUTIONS (5.6)]. Citalopram Clinical Impact: Increased exposure of citalopram leading to an increased risk of QT prolongation [see CLINICAL PHARMACOLOGY (12.3)]. Intervention: Limit the dose of citalopram to a maximum of 20 mg per day.

See prescribing information for citalopram. Cilostazol Clinical Impact: Increased exposure of cilostazol and one of its active metabolites (3,4-dihydro-cilostazol) [see CLINICAL PHARMACOLOGY (12.3)]. Intervention: Consider reducing the dose of cilostazol to 50 mg twice daily.

See prescribing information for cilostazol. Digoxin Clinical Impact: Potential for increased exposure of digoxin [see CLINICAL PHARMACOLOGY (12.3)]. Intervention: Monitor digoxin concentrations and adjust the dose, if needed, to maintain therap…

👥 Use in Specific Populations ~3 min read ▾

8. Use in Specific Populations

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with esomeprazole magnesium delayed-release capsules in pregnant women. Esomeprazole is the S-isomer of omeprazole. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use.

Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis for a 60 kg person). Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg.

When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age [see Data]. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Esomeprazole is the S-isomer of omeprazole. Four epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H2-receptor antagonists or other controls.

A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995 to 1999, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population.

The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. A population-based retrospective cohort study covering all live births in Denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.

A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an H2-blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively. A small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% with first trimester exposures).

The reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean b…

🆘 Overdosage 203 words ▾

10. Overdosage A single oral dose of esomeprazole at 510 mg/kg (about 124 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.

The symptoms described in connection with deliberate esomeprazole magnesium delayed-release capsules overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant.

Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert – Adverse Reactions). No specific antidote for esomeprazole is known.

Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered.

For current information on treatment of any drug overdose contact a Poison Control Center at 1-800-222-1222.

🧬 Clinical Pharmacology ~3 min read ▾

12. Clinical Pharmacology

12.1Mechanism of Action Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. The S- and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

This effect is dose-related up to a daily dose of 20 mg to 40 mg and leads to inhibition of gastric acid secretion.

12.2Pharmacodynamics Antisecretory Activity The effect of esomeprazole magnesium delayed-release capsules on intragastric pH was determined in patients with symptomatic gastroesophageal reflux disease in two separate studies. In the first study of 36 patients, esomeprazole magnesium delayed-release capsules 40 mg and 20 mg capsules were administered over 5 days. The results are shown in the Table 3: Table 3: Effect on Intragastric pH on Day 5 (N=36) Parameter Esomeprazole Magnesium Delayed-Release Capsules 40 mg Esomeprazole Magnesium Delayed-Release Capsules 20 mg % Time Gastric 70%2 53% pH >41 (Hours) (16.8 h) (12.7 h) Coefficient of variation 26% 37% Median 24 Hour pH 4.92

4.1Coefficient of variation 16% 27% 1. Gastric pH was measured over a 24-hour period 2. p<

0.01Esomeprazole Magnesium Delayed-Release Capsules 40 mg vs. Esomeprazole Magnesium Delayed-Release Capsules 20 mg In a second study, the effect on intragastric pH of esomeprazole magnesium delayed-release capsules 40 mg administered once daily over a five day period was similar to the first study, (% time with pH > 4 was 68% or 16.3 hours). Serum Gastrin Effects The effect of esomeprazole magnesium delayed-release capsules on serum gastrin concentrations was evaluated in approximately 2,700 patients in clinical trials up to 8 weeks and in over 1,300 patients for up to 6 to 12 months.

The mean fasting gastrin level increased in a dose-related manner. This increase reached a plateau within two to three months of therapy and returned to baseline levels within four weeks after discontinuation of therapy. Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum Chromogranin A (CgA) levels.

The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors. Healthcare providers should temporarily stop esomeprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. Enterochromaffin-like (ECL) Cell Effects In 24-month carcinogenicity studies of omeprazole in rats, a dose-related significant occurrence of gastric ECL cell carcinoid tumors and ECL cell hyperplasia was observed in both male and female animals [see NONCLINICAL TOXICOLOGY (13.1)].

Carcinoid tumors have also been observed in rats subjected to fundectomy or long-term treatment with other proton pump inhibitors or high doses of H2-receptor antagonists. Human gastric biopsy specimens have been obtained from more than 3,000 patients (both children and adults) treated with omeprazole in long-term clinical trials. The incidence of ECL cell hyperplasia in these studies increased with time; however, no case of ECL cell carcinoids, dysplasia, or neoplasia has been found in these patients.

In over 1,000 patients treated with esomeprazole magnesium (10, 20 or 40 mg/day) up to 6 to 12 months, the prevalence of ECL cell hyperplasia increased with time and dose. No patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa. Endocrine Effects Esomeprazole magnesium delayed-release capsules had no effect on thyroid function when given in oral doses of 20 or 40 mg for 4 weeks.

Other effects of esomeprazole magnesium delayed-release capsules on the endocrine system were assessed using omeprazole studies. Omeprazole given in oral doses of 30 or 40 mg for 2 to…

📦 How Supplied / Storage and Handling 90 words ▾

16. How Supplied/Storage and Handling Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg are white/white size ‘4’ hard gelatin capsules filled with white to off white spherical to oval pellets and imprinted with “I81” on body with gold tek ink. They are supplied as follows: Bottles of 30: NDC 80425-0111-01 Bottles of 60: NDC 80425-0111-02 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Keep esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules product package is subdivided.

📋 Description ~1 min read ▾

11. Description The active ingredient in the proton pump inhibitor esomeprazole magnesium delayed-release capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium dihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers.

(Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 2 H2O with molecular weight of 749.15 as a dihydrate and 713.12 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored powder.

It contains 2 moles of water of solvation and is practically insoluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.

Esomeprazole magnesium is supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.75 mg, or 43.5 mg esomeprazole magnesium dihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, and triethyl citrate.

In addition, the empty hard gelatin capsule shells contain gelatin and sodium lauryl sulfate. The capsule shells are imprinted with edible ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide. Meets USP Dissolution Test 2.

Structure

💬 Medication Guide ~3 min read ▾

Medication Guide Section MEDICATION GUIDE Esomeprazole Magnesium Delayed-Release Capsules USP (es'' oh mep' ra zole mag nee' zee um) Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules before you start taking esomeprazole magnesium delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about esomeprazole magnesium delayed-release capsules? Esomeprazole magnesium delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Esomeprazole magnesium delayed-release capsules can cause serious side effects, including: A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole magnesium delayed-release capsules, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.

Diarrhea. Esomeprazole magnesium delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.

Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

You should take esomeprazole magnesium delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take esomeprazole magnesium delayed-release capsules. Certain types of lupus erythematosus.

Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including esomeprazole magnesium delayed-release capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Esomeprazole magnesium delayed-release capsules can have other serious side effects. See “What are the possible side effects of esomeprazole magnesium delayed-release capsules?” What are esomeprazole magnesium delayed-release capsules? Esomeprazole magnesium delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI).

Esomeprazole magnesium delayed-release capsules reduce the amount of acid in your stomach. Esomeprazole magnesium delayed-release capsules are used in adults: for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). Esomeprazole magnesium delayed-release capsules may also be prescribed to heal acid-related damage to the lining of the esophagus (erosive esophagitis), and to help continue this healing.

GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping. for up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs). to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics amoxicillin and clarithromycin. for the long-term treatment of conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome.

Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more than normal amount of acid.…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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