signature care esomeprazole magnesium — Capsule, Delayed Release

Overview

Brand name

signature care esomeprazole magnesium

Generic name

Esomeprazole

Dosage form

Capsule, Delayed Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Safeway

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

3

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Esomeprazole	20 mg/1	606726	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Capsule, Delayed Release

Route of administration

Oral

Presentations

5

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Cytochrome P450 2C19 Inhibitors [MoA]	MoA	All 93 members
Proton Pump Inhibitor [EPC]	EPC	All 74 members
Proton Pump Inhibitors [MoA]	MoA	All 74 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

207193

Application type

ANDA · Abbreviated New Drug Application

Approval date

August 18, 2017

Sponsor

PERRIGO R AND D

Products on application

1

Submissions recorded

3

Products approved under application 207193.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
207193-001	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED RELEASE		ESOMEPRAZOLE MAGNESIUM	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 207193.
Type	No.	Action	Status	Date	Review
Supplement	11	Labeling	Approved	January 21, 2020	Standard
Supplement	3	Labeling	Approved	January 21, 2020	Standard
Original application	1		Approved	August 18, 2017	Standard

Review documents

0 · Supplement · January 6, 2021
0 · Supplement · January 6, 2021
0 · Original application · August 22, 2017
0 · Original application · August 22, 2017

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240726). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240726 HUMAN OTC DRUG · 20240726

Indications and Usage

openFDA Drug Labeling

Uses • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Purpose

openFDA Drug Labeling

Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions • adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • may take 1 to 4 days for full effect 14-Day Course of Treatment • swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Warnings

openFDA Drug Labeling

Warnings Allergy alert: • Do not use if you are allergic to esomeprazole. • Esomeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do Not Use

openFDA Drug Labeling

Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each capsule) Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22 mg esomeprazole magnesium dihydrate)

Adverse event reports

Source: openFDA FAERS

235,236

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ESOMEPRAZOLE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
21130-088-01	21130-088	Safeway	1 BOTTLE in 1 CARTON (21130-088-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	September 22, 2017
21130-088-03	21130-088	Safeway	3 BOTTLE in 1 CARTON (21130-088-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	September 22, 2017
21130-714-03	21130-714	Safeway	3 BOTTLE in 1 CARTON (21130-714-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	July 2, 2020
21130-088	21130-088	Safeway	—	September 22, 2017
21130-714	21130-714	Safeway	—	July 2, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.