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Omeprazole Magnesium
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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 BookCodes 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUse • 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 LabelingPurpose Acid reducer
Dosage and Administration
openFDA Drug LabelingDirections • 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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 LabelingStop 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 LabelingActive ingredient (in each capsule) * Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.