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Omeprazole Magnesium

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 Magnesium
Generic name
Omeprazole Magnesium
Dosage form
Capsule, Delayed Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
AstraZeneca Pharmaceuticals LP
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
16
Packages
42
Data completeness
82% 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 10 mg/1 198051 View
Omeprazole Magnesium 20 mg/1 198051 View
Omeprazole Magnesium 20.6 mg/1 198051 View
Omeprazole Magnesium 40 mg/1 198051 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Delayed Release
Route of administration
Oral
Presentations
58

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
078878
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 5, 2009
Sponsor
DR REDDYS LABS LTD
Products on application
1
Submissions recorded
11
Products approved under application 078878.
Product Trade name Form Strength Ingredient Status TE Flags
078878-001 OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE OMEPRAZOLE MAGNESIUM Over-the-counter — RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
No
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 078878.
Type No. Action Status Date Review
Supplement 42 Labeling Approved June 2, 2023 Standard
Supplement 32 Labeling Approved June 2, 2023 Standard
Supplement 30 Labeling Approved June 2, 2023 Standard
Supplement 28 Labeling Approved June 2, 2023 Standard
Supplement 22 Labeling Approved June 8, 2016 Standard
Supplement 10 Labeling Approved April 6, 2015 —
Supplement 15 Manufacturing (CMC) Approved February 14, 2014 Unknown
Supplement 12 Labeling Approved October 31, 2013 Standard
Supplement 11 Labeling Approved August 27, 2012 —
Supplement 6 Labeling Approved November 23, 2010 —
Original application 1 Approved June 5, 2009 —

Review documents

  • 0 · Original application · May 10, 2013

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250723). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250723 HUMAN OTC DRUG · 20250722 HUMAN OTC DRUG · 20250722 HUMAN OTC DRUG · 20250528

Indications and Usage

openFDA Drug Labeling

Use • 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 Acid reducer

Dosage and Administration

openFDA Drug Labeling

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 • 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 • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew or crush capsules. 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 . Heartburn in children may sometimes be caused by a serious condition.

Warnings Allergy alert: Do not use if you are allergic to omeprazole 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: warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus or mycophenolate mofetil (immune system medicines) prescription antiretrovirals (medicines for HIV infection) methotrexate (arthritis medicine) Stop use and ask 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 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 if you have: trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness c hest 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 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 If you develop rash or joint pain

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each capsule) * Omeprazole delayed-release capsules 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
21130-398-33 21130-398 Albertsons Companies 3 BOTTLE in 1 CARTON (21130-398-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE February 1, 2016
21130-398-52 21130-398 Albertsons Companies 1 BOTTLE in 1 CARTON (21130-398-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE February 1, 2016
0186-0606-00 0186-0606 AstraZeneca Pharmaceuticals LP 16000 CAPSULE, DELAYED RELEASE in 1 DRUM (0186-0606-00) January 1, 2015
0186-0742-00 0186-0742 AstraZeneca Pharmaceuticals LP 10000 CAPSULE, DELAYED RELEASE in 1 DRUM (0186-0742-00) January 1, 2015
0186-0743-00 0186-0743 AstraZeneca Pharmaceuticals LP 10000 CAPSULE, DELAYED RELEASE in 1 DRUM (0186-0743-00) January 1, 2015
69842-027-01 69842-027 CVS Health Corp. 3 BOTTLE in 1 CARTON (69842-027-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE October 1, 2015
69842-027-14 69842-027 CVS Health Corp. 1 BOTTLE in 1 CARTON (69842-027-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE November 1, 2011
69842-027-28 69842-027 CVS Health Corp. 2 BOTTLE in 1 CARTON (69842-027-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE November 1, 2011
69842-027-42 69842-027 CVS Health Corp. 3 BOTTLE in 1 CARTON (69842-027-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE November 1, 2011
68016-760-14 68016-760 Chain Drug Consortium, LLC 1 BOTTLE in 1 CARTON (68016-760-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
68016-760-28 68016-760 Chain Drug Consortium, LLC 2 BOTTLE in 1 CARTON (68016-760-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
68016-760-42 68016-760 Chain Drug Consortium, LLC 3 BOTTLE in 1 CARTON (68016-760-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
63868-177-15 63868-177 Chain Drug Marketing Association 1 BOTTLE in 1 CARTON (63868-177-15) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
63868-177-42 63868-177 Chain Drug Marketing Association 3 BOTTLE in 1 CARTON (63868-177-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
83324-117-14 83324-117 Chain Drug Marketing Association 1 BOTTLE in 1 CARTON (83324-117-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE November 1, 2024
83324-117-42 83324-117 Chain Drug Marketing Association 3 BOTTLE in 1 CARTON (83324-117-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE November 1, 2024
53943-520-14 53943-520 Discount Drug Mart, Inc 1 BOTTLE in 1 CARTON (53943-520-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE November 18, 2016
53943-520-42 53943-520 Discount Drug Mart, Inc 3 BOTTLE in 1 CARTON (53943-520-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE November 18, 2016
43598-813-14 43598-813 Dr. Reddy's Laboratories Inc. 1 BOTTLE in 1 CARTON (43598-813-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE December 26, 2018
43598-813-33 43598-813 Dr. Reddy's Laboratories Inc. 3 BOTTLE in 1 CARTON (43598-813-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE December 26, 2018
55111-397-27 55111-397 Dr. Reddy's Laboratories Limited 2 BOTTLE in 1 CARTON (55111-397-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE March 1, 2010
55111-397-28 55111-397 Dr. Reddy's Laboratories Limited 2 CARTON in 1 CARTON (55111-397-28) / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK March 1, 2010
55111-397-33 55111-397 Dr. Reddy's Laboratories Limited 3 BOTTLE in 1 CARTON (55111-397-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE March 1, 2010
55111-397-39 55111-397 Dr. Reddy's Laboratories Limited 3 BOTTLE in 1 CARTON (55111-397-39) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE September 1, 2015
55111-397-42 55111-397 Dr. Reddy's Laboratories Limited 3 CARTON in 1 CARTON (55111-397-42) / 2 BLISTER PACK in 1 CARTON (55111-397-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK March 1, 2010
55111-397-52 55111-397 Dr. Reddy's Laboratories Limited 1 BOTTLE in 1 CARTON (55111-397-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE March 1, 2010
55111-397-89 55111-397 Dr. Reddy's Laboratories Limited 1500 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-397-89) November 12, 2009
57896-759-14 57896-759 Gericare Pharmaceuticals 1 BOTTLE in 1 CARTON (57896-759-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE September 1, 2016
57896-759-28 57896-759 Gericare Pharmaceuticals 2 BOTTLE in 1 CARTON (57896-759-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE September 1, 2016
57896-759-42 57896-759 Gericare Pharmaceuticals 3 BOTTLE in 1 CARTON (57896-759-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE September 1, 2016
37808-006-33 37808-006 HEB 3 BOTTLE in 1 CARTON (37808-006-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
37808-006-52 37808-006 HEB 1 BOTTLE in 1 CARTON (37808-006-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
30142-012-01 30142-012 The Kroger Co. 2 BOTTLE in 1 CARTON (30142-012-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
30142-012-33 30142-012 The Kroger Co. 3 BOTTLE in 1 CARTON (30142-012-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
30142-012-52 30142-012 The Kroger Co. 1 BOTTLE in 1 CARTON (30142-012-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 1, 2016
49035-397-27 49035-397 Wal-Mart Stores Inc 2 BOTTLE in 1 CARTON (49035-397-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 15, 2010
49035-397-33 49035-397 Wal-Mart Stores Inc 3 BOTTLE in 1 CARTON (49035-397-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 15, 2010
49035-397-52 49035-397 Wal-Mart Stores Inc 1 BOTTLE in 1 CARTON (49035-397-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE January 15, 2010
0363-0042-01 0363-0042 Walgreens Company 3 BOTTLE in 1 CARTON (0363-0042-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE September 1, 2015
0363-0042-27 0363-0042 Walgreens Company 2 BOTTLE in 1 CARTON (0363-0042-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE September 1, 2015
0363-0042-33 0363-0042 Walgreens Company 3 BOTTLE in 1 CARTON (0363-0042-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE September 1, 2015
0363-0042-52 0363-0042 Walgreens Company 1 BOTTLE in 1 CARTON (0363-0042-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE September 1, 2015
21130-398 21130-398 Albertsons Companies — February 1, 2016
0186-0606 0186-0606 AstraZeneca Pharmaceuticals LP — January 1, 2015
0186-0742 0186-0742 AstraZeneca Pharmaceuticals LP — January 1, 2015
0186-0743 0186-0743 AstraZeneca Pharmaceuticals LP — January 1, 2015
69842-027 69842-027 CVS Health Corp. — November 1, 2011
68016-760 68016-760 Chain Drug Consortium, LLC — January 1, 2016
63868-177 63868-177 Chain Drug Marketing Association — January 1, 2016
83324-117 83324-117 Chain Drug Marketing Association — January 1, 2016
53943-520 53943-520 Discount Drug Mart, Inc — November 18, 2016
43598-813 43598-813 Dr. Reddy's Laboratories Inc. — December 26, 2018
55111-397 55111-397 Dr. Reddy's Laboratories Limited — November 12, 2009
57896-759 57896-759 Gericare Pharmaceuticals — April 1, 2013
37808-006 37808-006 HEB — January 1, 2016
30142-012 30142-012 The Kroger Co. — January 1, 2016
49035-397 49035-397 Wal-Mart Stores Inc — January 15, 2010
0363-0042 0363-0042 Walgreens Company — September 1, 2015

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 · 11 sections on this page.