Omeprazole is a proton pump inhibitor sold in the U.S. under 4 brand and generic names, for duodenal ulcer, esophagitis and gastroesophageal reflux. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Omeprazole (application ANDA204012). Other omeprazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Indication Recommended Adult ( 2.1 ) and Pediatric Dosage ( 2.2 ) Treatment of Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patientsmay require an additional 4 weeks ( 2.1 ) H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Omeprazole delayed-release capsules amoxicillin clarithromycin 20mg 1000mg 500mg Each drug twice daily for 10 days ( 2.1 )* Dual Therapy: Omeprazole delayed-release capsules Clarithromycin 40 mg once daily for 14 days** 500 mg three times daily for 14 days( 2.1 ) Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks ( 2.1 ) Symptomatic GERD 20 mg once daily for up to 4 weeks ( 2.1 ) See full prescribing information for weight based dosing in pediatric patients 2 years of age and older ( 2.2 ) EE due to Acid-Mediated GERD 20mg once daily for 4 to 8 weeks ( 2.1 )*** See full prescribing information for weight-based dosing in pediatric patients 2 years of age and older ( 2.2 ) Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily ( 2.1 )**** See full prescribing information for weight based dosing in pediatric patients 2 years of age and older ( 2.2 ) Pathological Hypersecretory Conditions Starting dose is 60 mg once daily (varies with individual patient, see full prescribing information) as long as clinically indicated ( 2.1 ) * if ulcer present, continue omeprazole delayed-release…
The following serious adverse reactions are described below and elsewhere in labeling: • Acute Interstitial Nephritis [see Warnings and Precautions ( 5.2 )] • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.3 )] • Bone Fracture [see Warnings and Precautions ( 5.4 )] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.5 )] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.7 )] • Hypomagnesemia [see Warnings and Precautions ( 5.8 )] • Fundic Gland Polyps [see Warnings and Precautions ( 5.12 )] Adults: Most common adverse reactions in adults (incidence ≥ 2%) are • Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. ( 6 ) Pediatric patients (2 to 16 years of age): • Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. ( 8.4 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience with Omeprazole Monotherapy Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 64/100 | Prescription | Capsule | — | — | View → | |
| 2 | Not yet rated | Prescription | Capsule | Generic | $2 | View → |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| E;67 | 20 mg | brown, pink | capsule | — |
| SG;364 | 40 mg / 1100 mg | blue | capsule | — |
| 20 | 20 mg / 1100 mg | white | capsule | — |
| 40 | 40 mg / 1100 mg | blue, white | capsule | — |
| SG;363 | 20 mg / 1100 mg | blue | capsule | — |
| SG;364 | 40 mg / 1100 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Dr. Reddy's Laboratories, Inc. · Jun 30, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc · May 13, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc · May 13, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg
Labeling: Not Elsewhere Classified - Wrong NDC number
Zydus Pharmaceuticals (USA) Inc · Nov 14, 2024
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1
Subpotent Drug: Out of specification for assay
Bausch Health Companies, Inc. · Feb 2, 2024
The elimination half-life of omeprazole is about 0.5 to 1 hour (roughly half an hour to an hour) in healthy adults. The half-life is longer in older adults (about 1 hour) and in people with chronic liver disease (nearly 3 hours); its metabolites have little or no activity, but because omeprazole irreversibly binds the stomach's acid pump, its acid-blocking effect lasts far longer than this short half-life would suggest.
OMEPRAZOLE capsule, delayed release — DailyMed (FDA label), Clinical Pharmacology / Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Omeprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6 )]. • Proton pump inhibitors (PPIs), including omeprazole delayed-release capsules, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions ( 7 )]. • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole delayed-release capsules, refer to the CONTRAINDICATIONS section of their package inserts. • Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation. ( 4 ) • Patients receiving rilpivirine-containing products. ( 4 , 7 ) • Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with omeprazole delayed-release capsules. ( 4 )
Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology ( 12.3 )]. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see Clinical Pharmacology ( 12.3 )]. • There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Intervention: Rilpivirine-containing products: Concomitant use with omeprazole is contraindicated [see Contraindications ( 4 )]. Atazanavir: Avoid concomitant use with omeprazole. See prescribing information for atazanavir for dosing information.…
| 3 | Not yet rated | Prescription | Powder | Generic | $2 | View → |
| 4 | Not yet rated | Over-the-counter | Tablet | — | — | View → |
| blue |
| capsule |
| — |
| 732 | 20 mg / 1100 mg | white | capsule | — |
|---|
| Omeprazole;20;mg;R158 | 20 mg | purple, gray | capsule | — |
|---|
| Z;69 | 20 mg | pink | rectangle | — |
|---|
| 186;20mg | 20 mg | white | capsule | — |
|---|
| 186;20mg | 20 mg | white | capsule | — |
|---|
| RG;50 | 20 mg | pink | capsule | — |
|---|