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omeprazole
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Omeprazole | 20 mg/1 | 200329 | View |
Forms, 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 |
|---|---|---|---|---|---|---|---|
| 209400-001 | OMEPRAZOLE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE | OMEPRAZOLE | Over-the-counter | — | RLD 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.
Patents and exclusivity
Source: Orange Book| Patent | Expires | Product | Substance | Use code | Submitted |
|---|---|---|---|---|---|
| 10835488 | December 8, 2036 | 001 | No | November 23, 2020 | |
| 10076494 | December 8, 2036 | 001 | No | September 18, 2018 |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 21 | Labeling | Approved | March 11, 2026 | Standard |
| Supplement | 12 | Labeling | Approved | October 21, 2022 | Standard |
| Supplement | 6 | Labeling | Approved | July 7, 2021 | Standard |
| Supplement | 10 | Labeling | Approved | November 13, 2020 | Standard |
| Supplement | 7 | Labeling | Approved | April 29, 2020 | Standard |
| Supplement | 5 | Labeling | Approved | January 28, 2019 | Standard |
| Supplement | 3 | Labeling | Approved | July 12, 2018 | Standard |
| Supplement | 2 | Labeling | Approved | June 12, 2018 | Standard |
| Supplement | 1 | Labeling | Approved | February 28, 2018 | Standard |
| Original application | 1 | Type 3 - New Dosage Form | Approved | July 5, 2017 | Standard |
Review documents
- 0 · Supplement · March 12, 2026
- 0 · Supplement · March 12, 2026
- 0 · Supplement · October 26, 2022
- 0 · Supplement · October 24, 2022
- 0 · Supplement · July 8, 2021
- 0 · Supplement · November 17, 2020
- 0 · Supplement · April 30, 2020
- 0 · Supplement · April 30, 2020
- 0 · Supplement · February 13, 2019
- 0 · Supplement · February 6, 2019
- 0 · Supplement · August 3, 2018
- 0 · Supplement · July 16, 2018
- 0 · Supplement · June 21, 2018
- 0 · Supplement · June 14, 2018
- 0 · Original application · March 21, 2018
- 0 · Supplement · March 15, 2018
- 0 · Supplement · March 1, 2018
- 0 · Original application · July 11, 2017
- 0 · Original application · July 11, 2017
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250305). 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 • take 1 tablet before eating in the morning • do not crush or chew tablets • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water. • 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 • do not take this medicine with alcohol Repeated 14-Day Course (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 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 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 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 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 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) Omeprazole 20 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: OMEPRAZOLE. 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 |
|---|---|---|---|---|
| 72288-666-55 | 72288-666 | Amazon.com Services LLC | 3 CARTON in 1 CARTON (72288-666-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | September 11, 2026 |
| 69842-791-55 | 69842-791 | CVS Pharmacy | 3 CARTON in 1 CARTON (69842-791-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | February 27, 2018 |
| 69842-791-74 | 69842-791 | CVS Pharmacy | 14 BLISTER PACK in 1 CARTON (69842-791-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 37808-354-55 | 37808-354 | H E B | 42 BLISTER PACK in 1 CARTON (37808-354-55) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | March 5, 2018 |
| 37808-354-74 | 37808-354 | H E B | 14 BLISTER PACK in 1 CARTON (37808-354-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | March 5, 2018 |
| 42507-164-42 | 42507-164 | HyVee Inc | 3 CARTON in 1 CARTON (42507-164-42) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | January 28, 2026 |
| 30142-394-55 | 30142-394 | Kroger Company | 3 CARTON in 1 CARTON (30142-394-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | April 10, 2018 |
| 41250-349-55 | 41250-349 | Meijer Distribution Inc | 3 CARTON in 1 CARTON (41250-349-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | March 13, 2018 |
| 0363-1819-55 | 0363-1819 | Walgreen Company | 3 CARTON in 1 CARTON (0363-1819-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | March 1, 2018 |
| 0363-1819-74 | 0363-1819 | Walgreen Company | 14 BLISTER PACK in 1 CARTON (0363-1819-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | March 6, 2018 |
| 72288-666 | 72288-666 | Amazon.com Services LLC | — | September 11, 2026 |
| 69842-791 | 69842-791 | CVS Pharmacy | — | February 27, 2018 |
| 37808-354 | 37808-354 | H E B | — | March 5, 2018 |
| 42507-164 | 42507-164 | HyVee Inc | — | January 28, 2026 |
| 30142-394 | 30142-394 | Kroger Company | — | April 10, 2018 |
| 41250-349 | 41250-349 | Meijer Distribution Inc | — | March 13, 2018 |
| 0363-1819 | 0363-1819 | Walgreen Company | — | March 1, 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 |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 13 sections on this page.