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Esomeprazole magnesium 20 mg Capsule, Coated Pellets, 90-count

by Asclemed USA, Inc. · 90 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-226-90)

NDC 76420-0226-90

🏷️ FDA NDC (as labeled) 76420-226-90 billing pads the product segment with a zero

This package

Contains90-count Pack sizes3 compare ↓

Also priced by: Part D plans $0.3386/unit — full pricing hub ↓

Also comes in: 30 capsules 76420-0226-30 60 capsules 76420-0226-60

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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 76420-226-90

Product NDC 76420-226

11-digit billing NDC 76420022690

NCPDP billing unit EA — each (per item)

RxCUI 606726, 606730

UNII R6DXU4WAY9

Application # ANDA210559

SPL Set ID 85a963c1-9c13-4eb7-826b-08d5a991fe28

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 2021-02-27

Route ORAL

Dosage form CAPSULE, COATED PELLETS

Substance 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 76420-226-90 — 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 → 76420-0226-90. 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

LabelerAsclemed USA, Inc.

Application holderINDCHEMIE HEALTH SPECIALTIES PVT LTD

FDA applicationANDA210559 (ANDA)

Labeler code76420

First marketedFeb 2021

Product typeHuman Prescription Drug

Portfolio652 products on file

🔎 All NDCs from Asclemed USA, Inc.

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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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 blue

ShapeCapsule

ImprintESOM;40

Size16 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 H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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 U72Q2I8C85
A mixture of fats derived from coconut oil that acts as an emulsifier and solubilizer. It helps blend oil and water-based ingredients together and improves how the body absorbs certain drugs.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 6HG8UB2MUY
Meglumine is a sugar-alcohol compound used as a solubilizer and pH buffer in medicines. It helps dissolve drugs that don't mix well in water and maintains stable acidity levels in the 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 LQA7B6G8JG
A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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 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.

17 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 system	Per each	Per 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	$30.47 / 90 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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 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 mgthis 76420-0226-90	Asclemed	90 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

🏛️

2021

On the market since

Feb 2021

📍

2026

Currently FDA-listed

5 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 — 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 NDC	Description	Marketing start	Status
76420-0226-30	30 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-226-30)	2022-07-27	Active
76420-0226-60	60 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-226-60)	2022-07-27	Active
76420-0226-90 You're viewing this	90 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-226-90)	2022-07-27	Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 76420-0226-90?

NDC 76420-0226-90 is a 90-count package — 90 capsule, coated pellets in 1 bottle.

What is the difference between NDC 76420-0226-90 and NDC 76420-0226-30?

Both are Esomeprazole magnesium 20 mg Capsule, Coated Pellets — the drug itself is identical. NDC 76420-0226-90 is the 90-count package, while NDC 76420-0226-30 is the 30 capsules package.

What NDC number is used to bill for this package of Esomeprazole magnesium 20 mg Capsule, Coated Pellets?

Bill NDC 76420-0226-90 — the 11-digit billing format is 76420022690. 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)	✓ 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 76420-226-90, 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: 76420-0226-90, written without dashes as 76420022690. 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 76420-0226-90, the first segment (76420) is the labeler code FDA assigned to Asclemed USA, Inc.; the middle segment (0226) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) 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 Asclemed USA, Inc.. 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 2 other package presentations of this same product, including 30 capsules (76420-0226-30), 60 capsules (76420-0226-60). 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?

Asclemed USA, Inc. 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

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsules, USP is a proton pump inhibitor indicated for the following: Treatment of gastroesophageal reflux disease (GERD) ( 1.1 ) Risk reduction of NSAID-associated gastric ulcer ( 1.2 ) H. pylori eradication to reduce the risk of duodenal ulcer recurrence ( 1.3 ) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome ( 1.4 )

1.1Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole magnesium is 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 may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium is indicated to maintain symptom resolution and healing of erosive esophagitis.

Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium is 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 is 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 plus amoxicillin and clarithromycin): esomeprazole magnesium, 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 is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Esomeprazole magnesium is supplied as delayed-release capsules, USP for oral administration. The recommended dosages are outlined in Table 1. esomeprazole magnesium should be taken at least one hour before meals. The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescribing information, and individual patient medical needs.

Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment. Table 1: Recommended Dosage Schedule of esomeprazole magnesium Indication Dose Frequency Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis 20 mg or 40 mg Once Daily for 4 to 8 Weeks 1 Maintenance of Healing of Erosive Esophagitis 20 mg Once Daily 2 Symptomatic Gastroesophageal Reflux Disease 20 mg Once Daily for 4 Weeks 3 Pediatric GERD 12 to 17 Year Olds Healing of Erosive Esophagitis 20 mg or 40 mg Once Daily for 4 to 8 Weeks Symptomatic GERD 20 mg Once Daily for 4 Weeks 1 to 11 Year Olds 4 Short-term Treatment of Symptomatic GERD 10 mg Once Daily for up to 8 Weeks Healing of Erosive Esophagitis weight < 20 kg weight > 20 kg 10 mg 10 mg or 20 mg Once Daily for 8 Weeks Once Daily for 8 Weeks Risk Reduction of NSAID-Associated Gastric Ulcer 20 mg or 40 mg Once Daily for up to 6 months 2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Esomeprazole magnesium 40 mg Once Daily for 10 Days Amoxicillin 1000 mg Twice Daily for 10 Days Clarithromycin 500 mg Twice Daily for 10 Days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 40 mg 5 Twice Daily 6 1 [ See Clinical Studies ( 14.1 ) ] The majority of 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 considered. 2 Controlled studies did not extend beyond six months. 3 If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

4 Doses over 1 mg/kg/day have not been studied. 5 The dosage of esomeprazole magnesium in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs.

6 Doses up to 240 mg daily have been administered [ see Drug Interactions ( 7 ) ]. Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients. Specific Populations Hepatic Insufficiency In patients with mild to moderate liver impairment (Child-Pugh Classes A and B), no dosage adjustment is necessary.

For patients with severe liver impairment (Child-Pugh Class C), a dose of 20 mg of esomeprazole magnesium should not be exceeded [ see Clinical Pharmacology ( 12.3 ) ]. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented in Table 2. Table 2: Administration Options Administration Options (See text following table for additional instructions.) Dosage Form Route Options Delayed-Release Capsules Oral Capsule can be swallowed whole. -or- Capsule can be opened and mixed with applesauce.

Delayed-Release Capsules Nasogastric Tube Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric tube Esomeprazole magnesium delayed-release capsules, USP Esomeprazole magnesium delayed-release capsules, USP should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the esomeprazole magnesium delayed-release capsules, USP can be opened, and the granules inside the capsule carefully emptied onto the applesauce.

The granules should be mixed with the applesauce and then swallowed immediately: do not store for future use. The a…

💊 Dosage Forms and Strengths 106 words ▾

3 DOSAGE FORMS AND STRENGTHS Esomeprazole magnesium delayed-release capsules, USP 20 mg – Light yellow to brown colored enteric coated pellets filled in size “4” hard gelatin capsule, opaque dark blue cap & opaque dark blue body printed “ESOM” on cap and “20” on the body in white ink. Esomeprazole magnesium delayed-release capsules, USP 40 mg – Light yellow to brown colored enteric coated pellets filled in size “3” hard gelatin capsule, opaque dark blue cap & opaque dark blue body printed “ESOM” on cap and “40” on the body in white ink.

Esomeprazole magnesium delayed-release capsules, USP: 20 mg and 40 mg ( 3 )

⛔ Contraindications 88 words ▾

4 CONTRAINDICATIONS Esomeprazole magnesium is 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, refer to the CONTRAINDICATIONS section of their package inserts.

Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred) ( 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 ) Clostridum difficle – 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 ) Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue esomeprazole magnesium and refer to specialist for evaluation.

( 5.5 ) Interaction with Clopidogrel: Avoid concomitant use of esomeprazole magnesium. ( 5.6 ) Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7 ) Hypomagnesemia: Reported rarely with prolonged treatment with PPIs.

( 5.8 ) Interaction with St. John’s Wort or Rifampin : Avoid concomitant use of esomeprazole magnesium. ( 5.9 , 7.3 ) Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increased chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors, temporarily stop esomeprazole magnesium at least 14 days before assessing CgA levels.

( 5.10 , 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. ( 5.11 , 7.7 ) Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year.

Use the shortest duration of therapy. ( 5.12 )

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with esomeprazole magnesium does 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 interstitial 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 nonspecific 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 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 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, 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 mul…

🤒 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 )] Most common adverse reactions ( 6.1 ): Adults (≥ 18 years) (incidence ≥ 1%) are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth Pediatric (1 to 17 years) (incidence ≥ 2%) are headache, diarrhea, abdominal pain, nausea, and somnolence To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) 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 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 6-12 months. In general, esomeprazole magnesium was 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 20 mg, 2,434 patients on esomeprazole magnesium 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 or omeprazole. Additional adverse reactions that were reported as possibly or probably related to esomeprazole magnesium 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 de…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS May affect plasma levels of antiretroviral drugs – use with atazanavir and nelfinavir is not recommended; if saquinavir is used with esomeprazole magnesium, monitor for toxicity and consider saquinavir dose reduction. ( 7.1 ) May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, erlotinib, digoxin and mycophenolate mofetil). Patients treated with esomeprazole magnesium and digoxin may need to be monitored for digoxin toxicity.

( 7.2 ) Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels.( 7.3 ) Clopidogrel: esomeprazole magnesium decreases exposure to the active metabolite of clopidogrel. ( 7.3 ) May increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction.

( 7.3 ) Tacrolimus: esomeprazole magnesium may increase serum levels of tacrolimus ( 7.5 ) Methotrexate: esomeprazole magnesium may increase serum levels of methotrexate. ( 7.7 )

7.1Interference with Antiretroviral Therapy Concomitant use of atazanavir and nelfinavir with proton pump inhibitors is not recommended. Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance. Co-administration of saquinavir with proton pump inhibitors is expected to increase saquinavir concentrations, which may increase toxicity and require dose reduction.

Omeprazole, of which esomeprazole is an enantiomer, has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug.

Other possible interaction mechanisms are via CYP2C19. Reduced concentrations of atazanavir and nelfinavir For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Following multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole (40 mg daily), AUC was decreased by 36% and 92%, C max by 37% and 89% and C min by 39% and 75% respectively for nelfinavir and M8.

Following multiple doses of atazanavir (400 mg, daily) and omeprazole (40 mg, daily, 2 hours before atazanavir), AUC was decreased by 94%, C max by 96%, and C min by 95%. Concomitant administration with omeprazole and drugs such as atazanavir and nelfinavir is therefore not recommended. Increased concentrations of saquinavir For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported, with an increase in AUC by 82%, in C max by 75%, and in C min by 106%, following multiple dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg daily co-administered days 11 to 15.

Therefore, clinical and laboratory monitoring for saquinavir toxicity is recommended during concurrent use with esomeprazole magnesium. Dose reduction of saquinavir should be considered from the safety perspective for individual patients. There are also some antiretroviral drugs of which unchanged serum levels have been reported when given with omeprazole.

7.2Drugs for Which Gastric pH Can Affect Bioavailability Due to its effects on gastric acid secretion, esomeprazole can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazole, atazanavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease, while the absorption of drugs such as digoxin can increase during treatment with esomeprazole. Esomeprazole is an enantiomer of omeprazole.

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (30% in two subjects). Co-administration of digoxin with esomep…

👥 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 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 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 ▾

🧒 Pediatric Use 197 words ▾

8.4Pediatric Use The safety and effectiveness of esomeprazole magnesium have been established in pediatric patients 1 to 17 years of age for short-term treatment (up to eight weeks) of GERD. 1 to 17 years of age Use of esomeprazole magnesium in pediatric and adolescent patients 1 to 17 years of age for short-term treatment (up to eight weeks) of GERD is supported by extrapolation of results from adequate and well-controlled studies for adults and safety and pharmacokinetic studies performed in pediatric and adolescent patients [ see Dosage and Administration (2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.3) ].

The safety and effectiveness of esomeprazole magnesium for other pediatric uses have not been established. Juvenile Animal Data 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 76 words ▾

8.5Geriatric Use Of the total number of patients who received esomeprazole magnesium in clinical trials, 1459 were 65 to 74 years of age and 354 patients were ≥ 75 years of age. 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 the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 201 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 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 to 40 mg and leads to inhibition of gastric acid secretion.

12.2Pharmacodynamics Antisecretory Activity The effect of esomeprazole magnesium 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 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 40 mg Esomeprazole magnesium 20 mg % Time Gastric pH >4 1 (Hours) Coefficient of variation Median 24 Hour pH Coefficient of variation 70% 2 (16.8 h) 26% 4.9 2 16% 53% (12.7 h) 37% 4.1 27% 1 Gastric pH was measured over a 24-hour period 2 p<

0.01Esomeprazole magnesium 40 mg vs. Esomeprazole magnesium 20 mg In a second study, the effect on intragastric pH of esomeprazole magnesium 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 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 H 2 -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 had no effect on thyroid function when given in oral doses of 20 or 40 mg for 4 weeks.

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

12.3 Pharmacokinetics Absorption Esomeprazole magnesium delayed-release caps…

🧬 Mechanism of Action 96 words ▾

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

📦 How Supplied / Storage and Handling 199 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Esomeprazole magnesium delayed-release capsules, USP 20 mg, are light yellow to brown colored enteric coated pellets filled in size “4” hard gelatin capsule, opaque dark blue cap & opaque dark blue body printed “ESOM” on cap and “20” on the body in white ink. They are supplied as follows: NDC 76420-226-30 bottles of 30 (relabeled and repackaged from 67877-571-XX) NDC 76420-226-60 bottles of 60 (repackaged from 67877-571-XX) NDC 76420-226-90 bottles of 90 (repackaged from 67877-571-XX) Esomeprazole magnesium delayed release capsules USP, 40 mg, are light yellow to brown colored enteric coated pellets filled in size “3” hard gelatin capsule, opaque dark blue cap & opaque dark blue body printed “ESOM” on cap and “40” on the body in white ink.

They are supplied as follows: NDC 76420-227-30 bottles of 30 (relabeled and repackaged from 67877-572-XX) NDC 76420-227-60 bottles of 60 (repackaged from 67877-572-XX) NDC 76420-227-90 bottles of 90 (repackaged from 67877-572-XX) Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules, USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules, USP 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]-1 H -benzimidazole-1-yl) magnesium trihydrate. 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 34 H 36 MgN 6 O 6 S 2 .3H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: Figure 1 The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble 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 25ºC and about 8 hours at 37ºC. Esomeprazole magnesium is supplied as Esomeprazole magnesium delayed-release capsules, USP.

Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated pellets with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, magnesium stearate, meglumine, methacrylic acid and ethyl acrylate copolymer dispersion, mono & diglycerides, poloxamer, sugar spheres, talc and triethyl citrate. The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: gelatin, FD & C Blue 1, FD & C Red 40, titanium dioxide, sodium lauryl sulphate and Imprinting Ink: potassium hydroxide, shellac, and titanium dioxide.

USP dissolution test is pending. esomeprazole-structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: · Hypersensitivity Reactions [see Contraindications (4) ] · Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] · Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] · Bone Fracture [see Warnings and Precaution (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) ] Drug Interactions • Advise patients to let you know if they are taking, or begin taking, other medications, because esomeprazole magnesium can interfere with antiretroviral drugs and drugs that are affected by gastric pH changes [see Drug Interactions (7.1) ] .

Administration · Let patients know that antacids may be used while taking esomeprazole magnesium. · Advise patients to take esomeprazole magnesium at least one hour before a meal. · For patients who are prescribed esomeprazole magnesium delayed-release capsules, USP advise them not to chew or crush the capsules. · Advise patients that, if they open esomeprazole magnesium delayed-release capsules, USP to mix the granules with food, the granules should only be mixed with applesauce. Use with other foods has not been evaluated and is not recommended. · For patients who are advised to open the esomeprazole magnesium delayed-release capsules, USP before taking them, instruct them in the proper technique for administration [see Dosage and Administration (2) ] and tell them to follow the dosing instructions in the PATIENT INFORMATION insert included in the package.

Instruct patients to rinse the syringe with water after each use. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Glossary — plain-language definitions of medical terms used in this label:

case series: A report describing what happened to a small group of patients, with no comparison group.

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

arthralgia: Joint pain.

asthenia: Unusual weakness or lack of physical strength and energy.

ataxia: Loss of muscle coordination that makes walking, balance, and controlled movements clumsy or unsteady.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

depression: A lasting low mood with loss of interest that affects everyday life.

diaphoresis: Heavy or excessive sweating.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dysphagia: Trouble or discomfort swallowing food, liquids, or pills.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

enteric-coated: A special coating that keeps a pill from dissolving in the stomach, so it opens up further along in the intestine.

epistaxis: A nosebleed.

eructation: The medical word for burping, or releasing gas from the stomach up through the mouth.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

gastroesophageal reflux disease: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

GERD: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

glycosuria: Sugar (glucose) in the urine, which often happens when blood sugar is high.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

hypoesthesia: A reduced sense of touch or feeling in part of the body, so it feels partly numb.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

interstitial nephritis: Inflammation of the tissue between the kidney's tiny filtering tubes, sometimes triggered by a medicine, that can reduce kidney function.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukocytosis: A higher-than-normal level of white blood cells, often a sign the body is fighting an infection.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

lymphadenopathy: Swollen or enlarged lymph nodes, often felt as lumps in the neck, armpits, or groin.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

melena: Black, sticky, tar-like stools caused by blood that has been digested higher up in the gut.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Nonclinical Toxicology: The label section summarizing safety findings from laboratory and animal studies, rather than from studies in people.

osteoporosis: A condition where bones become thin and weak, making them more likely to break.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

package insert: The detailed printed information about a medicine, written for health professionals, that comes with the product.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

relapse: The return of a cancer after a period of improvement or disappearance.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

susceptibility testing: A lab test that grows germs from a sample and checks which medicines can stop or kill them.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

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

← 76420-0225-30 · Asclemed 76420-0227-30 · Asclemed →

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.

Esomeprazole magnesium 20 mg Capsule, Coated Pellets, 90-count

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8 USE IN SPECIFIC POPULATIONS

12 CLINICAL PHARMACOLOGY

12.3 Pharmacokinetics Absorption Esomeprazole magnesium delayed-release caps…

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