Omeprazole
Product Images NDC 42254-053

12 FDA label images from Rebel Distributors Corp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Omeprazole (NDC 42254-053). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rebel Distributors Corp, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Chemical Structure (Fac73e19 3809 4846 8abc F42a47c224ae 01)

Chemical Structure (Fac73e19 3809 4846 8abc F42a47c224ae 01)
Chemical structure diagram showing the molecular structure of the active ingredient Omeprazole. The diagram includes its characteristic benzimidazole and pyridine rings with associated functional groups.*
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Table 6 (Fac73e19 3809 4846 8abc F42a47c224ae 02)

Table 6 (Fac73e19 3809 4846 8abc F42a47c224ae 02)
A data table comparing H. pylori eradication rates between two treatment regimens: Omeprazole plus clarithromycin plus amoxicillin and clarithromycin plus amoxicillin. The table shows Per-Protocol and Intent-to-Treat percentages of patients cured with 95% confidence intervals across three studies, including sample sizes. Footnotes explain patient inclusion criteria and statistical significance.*
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Table 7 (Fac73e19 3809 4846 8abc F42a47c224ae 03)

Table 7 (Fac73e19 3809 4846 8abc F42a47c224ae 03)
A data table presenting H. pylori eradication rates expressed as the percentage of patients cured with 95% confidence intervals. The table compares results from U.S. and Non U.S. studies at 4 to 6 weeks for treatments: Omeprazole plus Clarithromycin, Omeprazole alone, and Clarithromycin alone. Patient numbers for each study group are included, along with notes on statistical significance of differences.*
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Table 8 (Fac73e19 3809 4846 8abc F42a47c224ae 04)

Table 8 (Fac73e19 3809 4846 8abc F42a47c224ae 04)
A data table displaying duodenal ulcer recurrence rates by Helicobacter pylori eradication status. The table compares percentage of patients with ulcer recurrence in U.S. and non-U.S. studies at 6 and 12 months post-treatment, categorized by whether H. pylori was eradicated or not. Sample sizes for each study are included.*
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Graphic 1 (Fac73e19 3809 4846 8abc F42a47c224ae 05)

Graphic 1 (Fac73e19 3809 4846 8abc F42a47c224ae 05)
A data table showing the percentage of patients healed from gastric ulcers over 4 and 8 weeks. The table compares omeprazole 20 mg once daily, omeprazole 40 mg once daily, and placebo groups, with sample sizes included for each group. Statistical significance notes indicate omeprazole's effectiveness versus placebo and dosage comparison.*
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Graphic 2 (Fac73e19 3809 4846 8abc F42a47c224ae 06)

Graphic 2 (Fac73e19 3809 4846 8abc F42a47c224ae 06)
A data table showing the percentage of patients healed from gastric ulcers over 4 and 8 weeks for three treatments: Omeprazole 20 mg once daily, Omeprazole 40 mg once daily, and Ranitidine 150 mg twice daily. The table includes sample sizes and statistical significance notes comparing treatments.*
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Graphic 3 (Fac73e19 3809 4846 8abc F42a47c224ae 07)

Graphic 3 (Fac73e19 3809 4846 8abc F42a47c224ae 07)
A data table comparing the percentage of successful symptomatic outcomes for Omeprazole 20 mg a.m., Omeprazole 10 mg a.m., and placebo a.m. groups. It shows outcomes for all patients and patients with confirmed GERD, with sample sizes and statistical significance notes for comparisons between groups.*
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Graphic 4 (Fac73e19 3809 4846 8abc F42a47c224ae 08)

Graphic 4 (Fac73e19 3809 4846 8abc F42a47c224ae 08)
A data table comparing the number of subjects responding to treatment over weeks for 20 mg and 40 mg Omeprazole doses versus placebo. It presents weekly results for Week 4 and Week 8 with sample sizes noted for each group (n=83 for 20 mg, n=87 for 40 mg Omeprazole, and n=43 for placebo). Statistical significance is indicated for Omeprazole versus placebo at p < 0.01.*
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Graphic 5 (Fac73e19 3809 4846 8abc F42a47c224ae 09)

Graphic 5 (Fac73e19 3809 4846 8abc F42a47c224ae 09)
Data table comparing percent in endoscopic remission at 6 months among three groups: omeprazole 20 mg once daily (n=138), omeprazole 20 mg three days per week (n=137), and placebo (n=131). The table shows remission rates of 70%, 34%, and 11% respectively with a noted statistical significance for once daily dosing versus other groups.*
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Graphic 6 (Fac73e19 3809 4846 8abc F42a47c224ae 10)

Graphic 6 (Fac73e19 3809 4846 8abc F42a47c224ae 10)
A life table analysis comparing the percent of patients in endoscopic remission at 12 months among three groups: Omeprazole 20 mg once daily (n=131), Omeprazole 10 mg once daily (n=133), and Ranitidine 150 mg twice daily (n=128). The table shows remission percentages of 77% for Omeprazole 20 mg, a lower percentage for Omeprazole 10 mg, and 46% for Ranitidine with significance values noted for comparisons between groups.*
FDA Label Image

Omeprazole 10mg (Fac73e19 3809 4846 8abc F42a47c224ae 11)

Omeprazole 10mg (Fac73e19 3809 4846 8abc F42a47c224ae 11)
Omeprazole 10mg DR Capsules packaging label from Physician Partner, a division of Rebel Distributors Corp. The label indicates 120 capsules per package, each containing 10 mg Omeprazole. Capsules are size "3" hard gelatin with a lavender cap and yellow body, imprinted with OMEPRAZOLE and R157. Manufactured by Dr. Reddy's Laboratories Limited, India. Storage instructions specify controlled room temperature 15°-30°C (59°-86°F) and medication kept out of reach of children.*
FDA Label Image

Omeprazole 20mg (Fac73e19 3809 4846 8abc F42a47c224ae 12)

Omeprazole 20mg (Fac73e19 3809 4846 8abc F42a47c224ae 12)
Omeprazole 20mg DR Capsules label from Physician Partner, a division of Rebel Distributors Corp. The label indicates each delayed-release capsule contains 20mg Omeprazole USP. The capsules are size 2 with opaque lavender colored cap and opaque iron grey colored body, imprinted with OMEPRAZOLE 20mg and body R158 in black ink. Product ID Q0005372CA is shown. Manufacturer is Dr. Reddy's Laboratories Limited, India.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.