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Omeprazole 20 mg

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Omeprazole 20 mg
Generic name
Omeprazole 20 mg
Dosage form
Tablet, Delayed Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
MARKSANS PHARMA LIMITED
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
4
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
Omeprazole Magnesium 20 mg/1 198051 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Delayed Release
Route of administration
Oral
Presentations
6

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@FDANDC Directory
Application number
218829
Application type
ANDA · Abbreviated New Drug Application
Approval date
August 7, 2025
Sponsor
MARKSANS PHARMA
Products on application
1
Submissions recorded
2
Products approved under application 218829.
Product Trade name Form Strength Ingredient Status TE Flags
218829-001 OMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE OMEPRAZOLE MAGNESIUM Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 218829.
Type No. Action Status Date Review
Supplement 2 Manufacturing (CMC) Approved June 29, 2026 Unknown
Original application 1 Approved August 7, 2025 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260805). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260805 HUMAN OTC DRUG · 20250811

Indications and Usage

openFDA Drug Labeling

USE(S) 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 Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS Directions • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment o swallow 1 tablet with a glass of water before eating in the morning o take every day for 14 days o do not take more than 1 tablet a day o do not use for more than 14 days unless directed by your doctor o swallow whole. Do not chew, crush, or suck tablets . Repeated 14-Day Courses (if needed) o you may repeat a 14-day course every 4 months o 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. Heartburn in children may sometimes be caused by a serious condition.

Warnings

openFDA Drug Labeling

WARNINGS Warnings Allergy alert: • Do not use if you are allergic to omeprazole. • Omeprazole may cause severe skin reactions. Symptoms may include: o skin reddening o blisters o rash If an allergic reaction occurs, stop use and seek medical help right away.

Do Not Use

openFDA Drug Labeling

DO NOT USE 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 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 DOCTOR IF 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(S) Active ingredient (in each tablet) Omeprazole, USP delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)

Adverse event reports

Source: openFDA FAERS
444,608
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: OMEPRAZOLE MAGNESIUM. 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
25000-091-76 25000-091 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-091-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE August 12, 2025
25000-091-77 25000-091 MARKSANS PHARMA LIMITED 2 BLISTER PACK in 1 CARTON (25000-091-77) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK August 12, 2025
25000-094-76 25000-094 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-094-76) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE August 5, 2026
25000-094-81 25000-094 MARKSANS PHARMA LIMITED 1 BLISTER PACK in 1 CARTON (25000-094-81) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK August 5, 2026
25000-091 25000-091 MARKSANS PHARMA LIMITED — August 12, 2025
25000-094 25000-094 MARKSANS PHARMA LIMITED — August 5, 2026

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.