Omeprazole
Product Images NDC 45865-342

11 FDA label images from Medsource Pharmaceuticals · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Omeprazole (NDC 45865-342). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medsource Pharmaceuticals, 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

Pic 1 (Omeprazole Delayed Release 20mg 1)

Pic 1 (Omeprazole Delayed Release 20mg 1)
Chemical structure diagram showing the molecular structure of the active ingredient in Omeprazole by Medsource Pharmaceuticals. The diagram depicts atoms and bonds characteristic of the omeprazole molecule, illustrating its chemical composition.*
FDA Label Image

Pic 10 (Omeprazole Delayed Release 20mg 10)

Pic 10 (Omeprazole Delayed Release 20mg 10)
A data table titled 'Life Table Analysis' comparing endoscopic remission percentages at 12 months for three treatments: Omeprazole 20 mg once daily, Omeprazole 10 mg once daily, and Ranitidine 150 mg twice daily. The table includes sample sizes and notes statistical significance comparisons between groups.*
FDA Label Image

15 Tablet Label (Omeprazole Delayed Release 20mg 11)

15 Tablet Label (Omeprazole Delayed Release 20mg 11)
Label for Omeprazole Delayed Release Capsules 20 mg, generic for Prilosec, from Medsource Pharmaceuticals. The label includes dosage and administration instructions, capsule count (#15), lot number, expiration date, and identifies each capsule contains 20 mg Omeprazole. The label has bilingual dosing instructions in English and Spanish.*
FDA Label Image

Pic 2 (Omeprazole Delayed Release 20mg 2)

Pic 2 (Omeprazole Delayed Release 20mg 2)
A data table comparing Per-Protocol and Intent-to-Treat Helicobacter pylori eradication rates as percentages of patients cured with 95% confidence intervals. The table contrasts outcomes of Omeprazole plus clarithromycin and amoxicillin versus clarithromycin plus amoxicillin across three studies, including patient counts and notes on inclusion criteria and statistical significance.*
FDA Label Image

Pic 3 (Omeprazole Delayed Release 20mg 3)

Pic 3 (Omeprazole Delayed Release 20mg 3)
A data table presenting H. pylori eradication rates from per-protocol analysis at 4 to 6 weeks in U.S. and non-U.S. studies. The table compares the percentage of patients cured using Omeprazole plus Clarithromycin, Omeprazole alone, and Clarithromycin alone, showing sample sizes and 95% confidence intervals, with notes on statistical significance.*
FDA Label Image

Pic 4 (Omeprazole Delayed Release 20mg 4)

Pic 4 (Omeprazole Delayed Release 20mg 4)
A data table titled "Duodenal Ulcer Recurrence Rates by H. pylori Eradication Status" presenting the percentage of patients with ulcer recurrence. It compares H. pylori eradicated and not eradicated groups across U.S. and non-U.S. studies at 6 and 12 months post-treatment, including sample sizes. Footnotes clarify eradication status assessment timing and note combined treatment arms involving omeprazole.*
FDA Label Image

Pic 5 (Omeprazole Delayed Release 20mg 5)

Pic 5 (Omeprazole Delayed Release 20mg 5)
A data table comparing the percentage of patients healed from gastric ulcers after treatment with Omeprazole 20 mg once daily, Omeprazole 40 mg once daily, or placebo at weeks 4 and 8. The table presents statistical significance of healing rates between Omeprazole doses and placebo, and between the two Omeprazole doses.*
FDA Label Image

Pic 6 (Omeprazole Delayed Release 20mg 6)

Pic 6 (Omeprazole Delayed Release 20mg 6)
Data table showing the percentage of patients healed in the treatment of gastric ulcer comparing Omeprazole 20 mg once daily, Omeprazole 40 mg once daily, and Ranitidine 150 mg twice daily at weeks 4 and 8. Statistical significance notes indicate differences between dosages and drugs with p < 0.01.*
FDA Label Image

Pic 7 (Omeprazole Delayed Release 20mg 7)

Pic 7 (Omeprazole Delayed Release 20mg 7)
A data table displaying the percentage of successful symptomatic outcomes in patients treated with Omeprazole 20 mg a.m., Omeprazole 10 mg a.m., and placebo a.m. It includes results for all patients and for those with confirmed GERD, with statistical significance noted for comparisons between dosage groups and placebo.*
FDA Label Image

Pic 8 (Omeprazole Delayed Release 20mg 8)

Pic 8 (Omeprazole Delayed Release 20mg 8)
A data table presenting comparative weekly results for three groups: 20 mg Omeprazole (n=83), 40 mg Omeprazole (n=87), and Placebo (n=43). The table shows values for Week 4 and Week 8, with statistically significant differences noted between Omeprazole doses and placebo (p < 0.01).*
FDA Label Image

Pic 9 (Omeprazole Delayed Release 20mg 9)

Pic 9 (Omeprazole Delayed Release 20mg 9)
A data table titled 'Life Table Analysis' comparing percentages of 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 remission rates are 70%, 34%, and 11%, respectively, with a noted statistical significance (p < 0.01) for the once daily regimen versus the other groups.*

* 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.