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Acid Reducer
Omeprazole · Tablet, Delayed Release
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 |
|---|---|---|---|---|---|---|---|
| 206877-001 | OMEPRAZOLE MAGNESIUM | TABLET, DELAYED RELEASE | OMEPRAZOLE MAGNESIUM | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 12 | Labeling | Approved | November 8, 2024 | Standard |
| Supplement | 8 | Labeling | Approved | November 8, 2024 | Standard |
| Supplement | 5 | Labeling | Approved | November 8, 2024 | Standard |
| Supplement | 3 | Labeling | Approved | November 8, 2024 | Standard |
| Original application | 1 | Approved | June 6, 2018 | Standard |
Review documents
- 0 · Original application · January 8, 2018
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260604). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses 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 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush tablets. 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. • Omeprazole may cause severe skin reactions. Symptoms may Include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right way.
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 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 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 you develop a rash or joint pain
Active Ingredient
openFDA Drug LabelingActive ingredient (in each tablet) Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP trihydrate)
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 |
|---|---|---|---|---|
| 10202-722-05 | 10202-722 | 7-Eleven | 1 BOTTLE in 1 CARTON (10202-722-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 58602-729-01 | 58602-729 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-729-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | June 6, 2018 |
| 58602-729-02 | 58602-729 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-729-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | June 6, 2018 |
| 58602-729-03 | 58602-729 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-729-03) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | June 6, 2018 |
| 58602-729-05 | 58602-729 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-729-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 58602-729-61 | 58602-729 | Aurohealth LLC | 2 BOTTLE in 1 CARTON (58602-729-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 58602-729-62 | 58602-729 | Aurohealth LLC | 3 BOTTLE in 1 CARTON (58602-729-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 58602-729-65 | 58602-729 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-729-65) / 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (58602-729-64) | June 6, 2018 |
| 58602-826-05 | 58602-826 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-826-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 58602-826-61 | 58602-826 | Aurohealth LLC | 2 BOTTLE in 1 CARTON (58602-826-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 58602-826-62 | 58602-826 | Aurohealth LLC | 3 BOTTLE in 1 CARTON (58602-826-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 58602-850-05 | 58602-850 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-850-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | May 16, 2020 |
| 58602-850-62 | 58602-850 | Aurohealth LLC | 3 BOTTLE in 1 CARTON (58602-850-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | May 16, 2020 |
| 63941-006-05 | 63941-006 | Best Choice | 1 BOTTLE in 1 CARTON (63941-006-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 63941-006-62 | 63941-006 | Best Choice | 3 BOTTLE in 1 CARTON (63941-006-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 37835-189-14 | 37835-189 | Bi-Mart | 1 BOTTLE in 1 CARTON (37835-189-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 37835-189-42 | 37835-189 | Bi-Mart | 3 BOTTLE in 1 CARTON (37835-189-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 69842-679-14 | 69842-679 | CVS Pharmacy | 1 BOTTLE, PLASTIC in 1 CARTON (69842-679-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | December 31, 2021 |
| 69842-679-42 | 69842-679 | CVS Pharmacy | 3 BOTTLE, PLASTIC in 1 CARTON (69842-679-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | December 31, 2021 |
| 69842-941-01 | 69842-941 | CVS Pharmacy, Inc. | 1 BLISTER PACK in 1 CARTON (69842-941-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | September 23, 2020 |
| 69842-941-03 | 69842-941 | CVS Pharmacy, Inc. | 3 BLISTER PACK in 1 CARTON (69842-941-03) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | September 23, 2020 |
| 69842-941-05 | 69842-941 | CVS Pharmacy, Inc. | 1 BOTTLE in 1 CARTON (69842-941-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | September 23, 2020 |
| 69842-941-61 | 69842-941 | CVS Pharmacy, Inc. | 2 BOTTLE in 1 CARTON (69842-941-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | September 23, 2020 |
| 69842-941-62 | 69842-941 | CVS Pharmacy, Inc. | 3 BOTTLE in 1 CARTON (69842-941-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | September 23, 2020 |
| 70000-0521-1 | 70000-0521 | Cardinal Health | 1 BOTTLE in 1 CARTON (70000-0521-1) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 70000-0521-2 | 70000-0521 | Cardinal Health | 1 BLISTER PACK in 1 CARTON (70000-0521-2) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | October 21, 2020 |
| 70000-0521-3 | 70000-0521 | Cardinal Health | 2 BOTTLE in 1 CARTON (70000-0521-3) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | October 21, 2020 |
| 70000-0521-4 | 70000-0521 | Cardinal Health | 3 BOTTLE in 1 CARTON (70000-0521-4) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | October 21, 2020 |
| 53943-016-05 | 53943-016 | DISCOUNT DRUG MART | 1 BOTTLE in 1 CARTON (53943-016-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 53943-016-62 | 53943-016 | DISCOUNT DRUG MART | 3 BOTTLE in 1 CARTON (53943-016-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 55319-037-05 | 55319-037 | Family Dollar Stores, LLC | 1 BOTTLE in 1 CARTON (55319-037-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 17, 2024 |
| 55319-037-62 | 55319-037 | Family Dollar Stores, LLC | 3 BOTTLE in 1 CARTON (55319-037-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 17, 2024 |
| 55315-996-04 | 55315-996 | Fred's, Inc. | 3 BOTTLE in 1 CARTON (55315-996-04) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 55315-996-74 | 55315-996 | Fred's, Inc. | 1 BOTTLE in 1 CARTON (55315-996-74) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 57483-120-14 | 57483-120 | INNOVUS PHARMACEUTICALS, INC. | 1 BOTTLE in 1 CARTON (57483-120-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 4, 2026 |
| 57483-120-42 | 57483-120 | INNOVUS PHARMACEUTICALS, INC. | 3 BOTTLE in 1 CARTON (57483-120-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | May 25, 2023 |
| 30142-077-01 | 30142-077 | KROGER COMPANY | 1 BLISTER PACK in 1 CARTON (30142-077-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | March 13, 2023 |
| 30142-077-05 | 30142-077 | KROGER COMPANY | 1 BOTTLE in 1 CARTON (30142-077-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | March 13, 2023 |
| 80136-852-03 | 80136-852 | NORTHEAST PHARMA | 3 BOTTLE in 1 CARTON (80136-852-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | July 5, 2021 |
| 80136-852-42 | 80136-852 | NORTHEAST PHARMA | 3 BLISTER PACK in 1 CARTON (80136-852-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | January 13, 2022 |
| 69618-054-42 | 69618-054 | RELIABLE 1 LABORATORIES LLC | 3 BOTTLE in 1 CARTON (69618-054-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | March 11, 2021 |
| 0536-1322-13 | 0536-1322 | Rugby Laboratories | 3 BOTTLE in 1 CARTON (0536-1322-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | September 15, 2020 |
| 0536-1322-71 | 0536-1322 | Rugby Laboratories | 2 BOTTLE in 1 CARTON (0536-1322-71) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | September 15, 2020 |
| 0536-1322-88 | 0536-1322 | Rugby Laboratories | 1 BOTTLE in 1 CARTON (0536-1322-88) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | September 15, 2020 |
| 0363-1008-05 | 0363-1008 | WALGREEN CO. | 1 BOTTLE in 1 CARTON (0363-1008-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | May 6, 2021 |
| 0363-1008-61 | 0363-1008 | WALGREEN CO. | 2 BOTTLE in 1 CARTON (0363-1008-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | May 6, 2021 |
| 0363-1008-62 | 0363-1008 | WALGREEN CO. | 3 BOTTLE in 1 CARTON (0363-1008-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | May 6, 2021 |
| 49035-983-62 | 49035-983 | Wal-Mart Stores, Inc. | 3 BOTTLE in 1 CARTON (49035-983-62) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (49035-983-05) | June 6, 2018 |
| 67091-316-14 | 67091-316 | Winco Foods, LLC. | 1 BOTTLE in 1 CARTON (67091-316-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | June 6, 2018 |
| 10202-722 | 10202-722 | 7-Eleven | — | June 6, 2018 |
| 58602-729 | 58602-729 | Aurohealth LLC | — | June 6, 2018 |
| 58602-826 | 58602-826 | Aurohealth LLC | — | June 6, 2018 |
| 58602-850 | 58602-850 | Aurohealth LLC | — | May 16, 2020 |
| 63941-006 | 63941-006 | Best Choice | — | June 6, 2018 |
| 37835-189 | 37835-189 | Bi-Mart | — | June 6, 2018 |
| 69842-679 | 69842-679 | CVS Pharmacy | — | December 31, 2021 |
| 69842-941 | 69842-941 | CVS Pharmacy, Inc. | — | September 23, 2020 |
| 70000-0521 | 70000-0521 | Cardinal Health | — | June 6, 2018 |
| 53943-016 | 53943-016 | DISCOUNT DRUG MART | — | June 6, 2018 |
| 55319-037 | 55319-037 | Family Dollar Stores, LLC | — | June 17, 2024 |
| 55315-996 | 55315-996 | Fred's, Inc. | — | June 6, 2018 |
| 57483-120 | 57483-120 | INNOVUS PHARMACEUTICALS, INC. | — | May 25, 2023 |
| 30142-077 | 30142-077 | KROGER COMPANY | — | March 13, 2023 |
| 80136-852 | 80136-852 | NORTHEAST PHARMA | — | July 5, 2021 |
| 69618-054 | 69618-054 | RELIABLE 1 LABORATORIES LLC | — | March 11, 2021 |
| 0536-1322 | 0536-1322 | Rugby Laboratories | — | September 15, 2020 |
| 0363-1008 | 0363-1008 | WALGREEN CO. | — | May 6, 2021 |
| 49035-983 | 49035-983 | Wal-Mart Stores, Inc. | — | June 6, 2018 |
| 67091-316 | 67091-316 | Winco Foods, LLC. | — | June 6, 2018 |
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.