Home › NDC Lookup › Ingredients › Esomeprazole Magnesium › 65862-0783-78
Esomeprazole Magnesium 20 mg Capsule, Delayed Release — NDC 65862-0783-78 package photo

Esomeprazole Magnesium 20 mg Capsule, Delayed Release

by Aurobindo Pharma Limited · 10 BLISTER PACK in 1 CARTON (65862-783-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-783-10)
NDC 65862-0783-78
🏷️ FDA NDC (as labeled) 65862-783-78 billing pads the product segment with a zero
This package
Contains10 capsule, delayed release in 1 blister pack Pack sizes7 compare ↓
Also priced by: Part D plans $0.3386/unit — full pricing hub ↓
Also comes in: 30 capsules 65862-0783-30 90 capsules 65862-0783-90 100 capsules 65862-0783-01 1000 capsules 65862-0783-99 5000 capsules 65862-0783-59 50000 capsules 65862-0783-50
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) 65862-783-78
Product NDC 65862-783
11-digit billing NDC 65862078378
RxCUI 606726, 606730
UNII 36H71644EQ
Application # ANDA205606
SPL Set ID f4ae091d-9b74-4a0e-ac68-057effd91e17
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
GPI-14 49270025106520
GPI class Esomeprazole Magnesium
GCN Seq No 047525
GCN 12867
HICL code 021607
Ingredient (HICL) Esomeprazole Magnesium
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4J
Therapeutic class — specific (HIC3) Proton-Pump Inhibitors
AHFS code 56:28.36.00
AHFS class Proton-Pump Inhibitors
FDB label name ESOMEPRAZOLE MAG DR 20 MG CAP
FDB brand name Esomeprazole Magnesium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 65862-783-78 — a 5-3-2 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 product segment → 65862-0783-78. 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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA205606 (ANDA)
Labeler code65862
First marketedApr 2016
Product typeHuman Prescription Drug
Portfolio1,447 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

Label name ESOMEPRAZOLE MAG DR 20 MG CAP Ingredient Esomeprazole Magnesium
📗 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
ImprintI82
Size18 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 8PJ61P6TS3
    Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII WVK1CT5994
    A plant-derived emulsifier made from coconut oil and glycerin. It helps blend oily and watery ingredients together in the medicine and improves texture and spreadability.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 0E53J927NA
    Magnesium carbonate is a mineral powder used in medicines as a filler to add bulk and as a buffer to help regulate acidity in the formulation.
  • UNII 3A3U0GI71G
    Magnesium oxide is a mineral compound that acts as a buffer and filler in medications. It helps neutralize stomach acid and adds bulk to the tablet or capsule formulation.
  • UNII NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

22 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 $33.86 / 100 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 $0.153 AB Availability likely —
Esomeprazole Magnesium 20 mg 16714-0979-01 NorthStar 30 capsules $0.153 AB Availability likely —
Esomeprazole Magnesium 20 mg 31722-0664-10 Camber 1000 capsules $0.153 AB Availability likely —
Esomeprazole magnesium 20 mg 43547-0001-03 Solco 30 capsules $0.153 AB Availability likely —
Esomeprazole Magnesium 20 mg 43598-0509-10 Dr. 1000 capsules $0.153 AB Availability likely —
Esomeprazole Magnesium 20 mg 62175-0820-32 Lannett 30 capsules $0.153 AB Availability likely —
Esomeprazole magnesium 20 mg 63304-0734-10 Sun 1000 capsules $0.153 AB Availability likely —
Esomeprazole magnesium 20 mg 64980-0632-03 Rising 30 capsules $0.153 AB Availability likely —
esomeprazole magnesium 20 mg 68382-0441-06 Zydus 30 capsules $0.153 AB Availability likely —
Esomeprazole Magnesium 20 mg 70069-0814-10 Somerset 1000 capsules $0.153 AB Availability likely —
esomeprazole magnesium 20 mg 70377-0055-11 Biocon 30 capsules $0.153 AB Availability likely —
Esomeprazole Magnesium 20 mg 82009-0033-10 Quallent 1000 capsules $0.153 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 $0.349 — Availability likely —
Esomeprazole Magnesium 20 mg 16571-0880-41 Rising 14 capsules $0.349 — Availability likely —
Good Neighbor Pharmacy Esomeprazole Magnesium 20 mg 46122-0641-04 Amerisource 14 capsules $0.349 — Availability likely —
Esomeprazole Magnesium 20 mg 46122-0736-03 Amerisource 14 capsules $0.349 — Availability likely —
Esomeprazole Magnesium 20 mg 69230-0320-31 Camber 14 capsules $0.349 — Availability likely —
leader esomeprazole magnesium 20 mg 70000-0727-01 Cardinal 14 capsules $0.349 — Availability likely —
Esomeprazole Magnesium 20 mg 70000-0731-01 LEADER/ 14 capsules $0.349 — Availability likely —
Foster and Thrive Acid Reducer 20 mg 70677-1099-01 Strategic 14 capsules $0.349 — 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 $8.781 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 mgthis 65862-0783-78 Aurobindo 10 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 mg 80425-0111-01 Advanced 30 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 capsules65862-0783-30 20,703 Rx · $384,812
100 capsules65862-0783-01 No Medicaid data
10 capsules this page65862-0783-78 No Medicaid data
90 capsules65862-0783-90 No Medicaid data
1000 capsules65862-0783-99 No Medicaid data
50000 capsules65862-0783-50 No Medicaid data
5000 capsules65862-0783-59 No Medicaid data
Drug total (last 4 qtrs): 20,703 Rx · 1,010,562 units · $384,812 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Esomeprazole Magnesium — 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. 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
65862-0783-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-783-01) — — 2016-04-21 Active
65862-0783-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-783-30) $0.1533 / ea $4.60 2016-04-21 Active
65862-0783-78 You're viewing this 10 BLISTER PACK in 1 CARTON (65862-783-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-783-10) — — 2016-04-21 Active
65862-0783-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-783-90) $0.1533 / ea $13.79 2016-04-21 Active
65862-0783-99 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-783-99) — — 2016-04-21 Active
65862-0783-50 50000 CAPSULE, DELAYED RELEASE in 1 BAG (65862-783-50) — — — Active
65862-0783-59 5000 CAPSULE, DELAYED RELEASE in 1 BAG (65862-783-59) — — — Active

This pack shows little to no recent Medicaid volume — the 30 capsules pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 65862-0783-78?
NDC 65862-0783-78 is listed by the FDA — 10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack.
What NDC number is used to bill for this package of Esomeprazole Magnesium 20 mg Capsule, Delayed Release?
Bill NDC 65862-0783-78 — the 11-digit billing format is 65862078378. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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) ✓ 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.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65862-783-78, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65862-0783-78, written without dashes as 65862078378. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65862-0783-78, the first segment (65862) is the labeler code FDA assigned to Aurobindo Pharma Limited; the middle segment (0783) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (78) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurobindo Pharma Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 30 capsules (65862-0783-30), 90 capsules (65862-0783-90), 100 capsules (65862-0783-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aurobindo Pharma Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules 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. ( 1.1 ) Maintenance of healing of EE in adults.

( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4 ) Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.

( 1.5 ) Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6 )

1.1Healing of Erosive Esophagitis (EE) Adults 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 EE in adults. 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age.

1.2Maintenance of Healing of EE Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.

1.3Treatment of Symptomatic GERD Adults 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.

1.4Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (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 adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

1.5Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Esomeprazole magnesium delayed-release capsules in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori . 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 ].

1.6Pathological 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, in adults.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Population Recommended Adult ( 2.1 ) and Pediatric Dosage ( 2.2 ) Healing of EE (12 years and older) Adults 20 mg or 40 mg 1 once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks 12 years to 17 years 20 mg or 40 mg 1 once daily for 4 to 8 weeks Maintenance of Healing of EE Adults 20 mg once daily. Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD Adults 20 mg once daily for 4 weeks some patients may require an additional 4 weeks 12 years to 17 years 20 mg once daily for 4 weeks Risk Reduction of NSAID-Associated Gastric Ulcer Adults 20 mg or 40 mg 1 once daily for up to 6 months 2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Adults Esomeprazole magnesium delayed-release capsules 40 mg 1 once daily for 10 days Amoxicillin 1000 mg twice daily for 10 days 3 Clarithromycin 500 mg twice daily for 10 days 3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults Starting dosage is 40 mg twice daily 4 (varies with the individual patient) 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). 2 Controlled studies do not extend beyond 6 months. 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). Preparation and Administration Information Swallow capsules whole; do not crush or chew. For patients who cannot swallow intact capsule, the capsule can be opened, and the contents mixed with applesauce.

( 2.3 ) Opened capsules can be administered through a nasogastric tube. ( 2.3 )

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 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) ] .

Adult Indication Recommended Dosage of Esomeprazole Magnesium Delayed-Release Capsules Treatment Duration Healing of EE 20 mg or 40 mg 1 once daily 4 to 8 weeks 2 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 mg 1 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 daily 1 Amoxicillin 1000 mg twice daily 3 Clarithromycin 500 mg twice daily 3 10 days 10 days 10 days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Starting dosage is 40 mg twice daily 4 ; individualize the r…

💊 Dosage Forms and Strengths 87 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. Esomeprazole Magnesium Delayed-Release Capsules USP: 20 mg and 40 mg esomeprazole.

( 3 )

⛔ Contraindications 155 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 (6.2) ]. For information about contraindications of amoxicillin and clarithromycin, indicated in combination with esomeprazole magnesium delayed-release capsules for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information.

Proton pump inhibitors (PPIs), including esomeprazole magnesium delayed-release capsules, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] . Known hypersensitivity to substituted benzimidazoles or any component of the formulation. ( 4 ) Patients receiving rilpivirine-containing products.

( 4 , 7 ) Refer to the Contraindications section of the prescribing information for amoxicillin and clarithromycin, when administered in combination with esomeprazole magnesium delayed-release capsules. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients.

( 5.2 ) Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.3 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

( 5.5 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue esomeprazole magnesium delayed-release capsules and refer to specialist for evaluation. ( 5.6 ) Interaction with Clopidogrel : Avoid concomitant use of esomeprazole magnesium delayed-release capsules. ( 5.7 ) Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.

( 5.8 ) Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs. ( 5.9 ) Interaction with St. John’s Wort or Rifampin : Avoid concomitant use of esomeprazole magnesium delayed-release capsules.

( 5.10 , 7 ) Interactions with Diagnostic Investigations for Neuroendocrine Tumors : Increased chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors, temporarily stop esomeprazole magnesium delayed-release capsules at least 14 days before assessing CgA levels. ( 5.11 , 12.2 ) Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider temporary withdrawal of esomeprazole magnesium delayed-release capsules.

( 5.12 , 7 ) Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. ( 5.13 )

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…

🤒 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) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.8) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.9) ] Fundic Gland Polyps [see Warnings and Precautions (5.13) ] Most common adverse reactions ( 6.1 ): Adults (≥ 18 years) (≥1%) are: headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.

Pediatrics (1 to 17 years) (≥2%) are: headache, diarrhea, abdominal pain, nausea, and somnolence. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. The safety in the treatment of healing of EE in adults was assessed in four randomized comparative clinical trials, which included 1,240 patients who received esomeprazole magnesium delayed-release capsules 20 mg once daily, 2,434 patients on esomeprazole magnesium delayed-release capsules 40 mg once daily, and 3,008 patients on omeprazole 20 mg once daily. The most frequently occurring adverse reactions (at least 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. Less common adverse reactions with an incidence of less than 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,…

🔄 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 [see 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 (5.12) ]. 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 (5.7) ].

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 mainta…

👥 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 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 (see Data) .

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 H 2 -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 H 2 -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 H 2 -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 birth weight were…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with esomeprazole 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 (see Data) .

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 H 2 -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 H 2 -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 H 2 -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 birth weight were similar among the groups. Sev…

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Healing of EE Pediatric Patients 1 Year to 17 Years of Age The safety and effectiveness of esomeprazole magnesium delayed-release capsules have been established in pediatric patients 12 years to 17 years for short-term treatment (4 to 8 weeks) for healing of EE. Use of esomeprazole magnesium delayed-release capsules for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data in pediatric patients 1 year to 17 years of age.

The safety profile in pediatric patients 1 year to 17 years of age was similar to adults [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.4) ] . Symptomatic GERD Pediatric Patients 1 Year to 17 Years of Age The safety and effectiveness of esomeprazole magnesium delayed-release capsules have been established in pediatric patients 12 years to 17 years of age for the short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD. Use of esomeprazole magnesium delayed-release capsules for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data in pediatric patients 1 year to 17 years of age.

The safety profile in pediatric patients 1 year to 17 years of age was similar to adults [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.4) ] . Other Conditions The safety and effectiveness of esomeprazole magnesium delayed-release capsules for the risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence and treatment of pathological hypersecretory conditions have not been established in pediatric patients. Juvenile Animal Toxicity Studies In a juvenile rat toxicity study, esomeprazole was administered with both magnesium and strontium salts at oral doses about 34 to 68 times a daily human dose of 40 mg based on body surface area.

Increases in death were seen at the high dose, and at all doses of esomeprazole, there were decreases in body weight, body weight gain, femur weight and femur length, and decreases in overall growth [see Nonclinical Toxicology (13.2) ] .

🧓 Geriatric Use 78 words ▾

8.5Geriatric Use Of the total number of patients who received esomeprazole magnesium delayed-release capsules in clinical trials, 1459 were 65 to 74 years of age and 354 patients were 75 years of age and older. No overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 111 words ▾

10 OVERDOSAGE Manifestations in patients exposed to omeprazole, the racemic mixture, at doses up to 2,400 mg (120 times the usual recommended clinical dose) include confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen at recommended dosages. See the full prescribing information for omeprazole for complete safety information. 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. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Esomeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Esomeprazole is protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, esomeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.

This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

12.2Pharmacodynamics Antisecretory Activity Adults The effect of esomeprazole on intragastric pH was determined in adult patients with symptomatic GERD in two separate studies. In the first study of 36 patients, esomeprazole magnesium 40 mg and 20 mg delayed-release capsules were administered once daily over 5 days as shown in Table 5: Table 5: Effect of Esomeprazole on Intragastric pH on Day 5 (N=36) Following Once Daily Dosing of Esomeprazole Magnesium Delayed-Release Capsules in Adult Patients with Symptomatic GERD 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 Parameter Esomeprazole Magnesium Delayed-Release Capsules 40 mg once daily 20 mg once daily % Time Gastric pH >4 1 (Hours) 70% 2 (16.8 h) 53% (12.7 h) Coefficient of variation 26% 37% Median 24 Hour pH 4.9 2

4.1Coefficient of variation 16% 27% In a second study, the effect on intragastric pH of esomeprazole magnesium 40 mg delayed-release capsules 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 on serum gastrin concentrations was evaluated in approximately 2,700 patients in clinical trials of oral esomeprazole for up to 8 weeks and in over 1,300 patients for up to 12 months. The mean fasting gastrin level increased in a dose-related manner.

The increase in serum gastrin concentrations 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 [see Warnings and Precautions (5.11) ] Enterochromaffin-like (ECL) Cell Effects Human gastric biopsy specimens have been obtained from more than 3,000 patients (both pediatrics 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 [see Nonclinical Toxicology (13.1) ] In over 1,000 patients treated with oral esomeprazole (10 mg, 20 mg or 40 mg/day) for up 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 had no effect on thyroid function in adults when given esomeprazole 20 mg or 40 mg delayed-release capsules once daily for 4 weeks.

Other effects of esomeprazole on the endocrine system were assessed in studies of omeprazole. Oral doses of omeprazole 30 mg or 40 mg once daily for 2 to 4 weeks had no effect on carbohydrate metabolism, circulating levels of parathyroid hormone, cortisol, estradiol, testosterone, prolactin, cholecystokinin, or secretin.

12.3Pharmacokinetics Absorption Esomeprazole magnesium delayed-release capsules showed similar bioavailability after a single dose (40 mg) a…

🧬 Mechanism of Action 111 words ▾

12.1Mechanism of Action Esomeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Esomeprazole is protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, esomeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.

This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

📦 How Supplied / Storage and Handling 173 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 65862-783-30 Bottles of 90 NDC 65862-783-90 Bottles of 100 NDC 65862-783-01 Bottles of 1,000 NDC 65862-783-99 10 x 10 Unit-dose Capsules NDC 65862-783-78 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.

They are supplied as follows: Bottles of 30 NDC 65862-784-30 Bottles of 90 NDC 65862-784-90 Bottles of 100 NDC 65862-784-01 Bottles of 1,000 NDC 65862-784-99 10 x 10 Unit-dose Capsules NDC 65862-784-78 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 esomeprazole magnesium delayed-release capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium dihydrate, a PPI. 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 (C 17 H 18 N 3 O 3 S) 2 Mg x 2 H 2 O 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 esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate USP) or 40 mg of esomeprazole (equivalent to 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 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.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Acute Tubulointerstitial Nephritis Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with suspected acute TIN [see Warnings and Precautions (5.2) ] . Clostridium difficile -Associated Diarrhea Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3) ] .

Bone Fracture Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions Advise the patient or caregiver to discontinue esomeprazole magnesium delayed-release capsules and immediately call the patient’s healthcare provider for at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity signs or symptoms associated with Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ].

Cutaneous and Systemic Lupus Erythematosus Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.6) ]. Cyanocobalamin (Vitamin B-12) Deficiency Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving esomeprazole magnesium delayed-release capsules for longer than 3 years [see Warnings and Precautions (5.8) ] .

Hypomagnesemia and Mineral Metabolism Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to the patient’s healthcare provider, if they have been receiving esomeprazole magnesium delayed-release capsules for at least 3 months [see Warnings and Precautions (5.9) ] . Drug Interactions Advise the patient or caregiver to report to their healthcare provider if starting treatment with rilpivirine-containing products, clopidogrel, St. John’s Wort or rifampin; or, if they take high-dose methotrexate [see Contraindications (4) , Warnings and Precautions (5.7 , 5.10 , 5.12) ].

Administration Take esomeprazole magnesium delayed-release capsules at least one hour before meals. Antacids may be used concomitantly with esomeprazole magnesium delayed-release capsules. 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 is not recommended. Add one tablespoon of applesauce to an empty bowl.

The applesauce used should not be hot and should be soft enough to be swallowed without chewing. Open the esomeprazole magnesium delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce. Mix the granules with the applesauce.

Administer the mixture immediately. Do not chew or crush the granules Discard any remaining mixture. Do not store the mixture for future use.

Esomeprazole magnesium delayed-release capsules can also be administered via a nasogastric tube, as described in the Instructions for Use . Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 03/2025 The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

💬 Medication Guide ~3 min read ▾

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides MEDICATION GUIDE Esomeprazole Magnesium (es'' oh mep' ra zole mag nee' zee um) Delayed-Release Capsules USP, for oral use 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 tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole magnesium delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

Diarrhea caused by an infection ( Clostridium difficile ) in your intestines . Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.

Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.

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. Talk to your doctor about your risk of these serious side effects. 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? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. Esomeprazole magnesium delayed-release capsules are used in adults for: 4 to 8 weeks for the healing and symptom relief of acid-related damage to the esophagus (erosive esophagitis or EE).

Your doctor may prescribe another 4 to 8 weeks of esomeprazole magnesium delayed-release capsules in patients whose EE does not heal. maintaining healing of EE. 4 to 8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs). treating patients with a stomach infection ( Helicobacter pylori ) and a stomach ulcer, along with the antibiotics amoxicillin and clarithromycin. 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. Esomeprazole magnesium delayed-release capsules are used in children and adolescents 12 to 17 years of age for: 4 to 8 weeks to heal EE. 4 weeks to treat heartburn and other symptoms that happen with GERD.

It is not known if esomeprazole magnesium delayed-release capsules are safe and effective in children to reduce the risk of stomach ulcers in children who take medicines called NSAIDs, to treat Helicobacter pylori stomach infection to lower the risk of a stomach ulcer returning, and to treat conditions where your stomach makes too much acid. Do not take esomeprazole magnesium delayed-release capsule…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65862-0782-01 · Aurobindo 65862-0784-01 · Aurobindo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.