Not Applicable
Product Images NDC 69336-112

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Not Applicable (NDC 69336-112). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sterling Knight Pharmaceuticals Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Image Description (Omeprazolelabel)

This appears to be a label for a medication called Omeprazole manufactured by SceGen Pharmaceuticals Inc., located in Hauppauge, NY. The label provides information on the size of the medication at 1.75 inches wide and 4.5 inches long. The medication is approved for use in various temperatures, including room temperature. It is distributed by EGP Pharmaceuticals in Bogue Chitto, MS and has an NDC code of 69336-112:30.*

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Structure (Structure)

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Table1 (Table1)

This is a table outlining the recommended doses of Omeprazole and Sodium Bicarbonate for different indications in adults aged 18 years and older. The indications include short-term treatment of active duodenal ulcer, benign gastric ulcer, gastroesophageal reflux disease (GERD), symptomatic GERD (with no esophageal erosions), erosive esophagitis, and maintenance of healing of erosive esophagitis. The recommended doses range from 20mg to 40mg once daily for up to 8 weeks. Clinical studies are referenced in the table for additional information.*

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Tab10 (Table10)

Table 10 shows the percentage of patients with gastric ulcer who were healed after treatment with Omeprazole (40mg q.d. and 20 mg q.d.) and Ranitidine (150 mg b.i.d.). The table depicts patient data over the course of 4 and 8 weeks. The results show that Omeprazole outperforms Ranitidine in terms of ulcer healing. The P-values indicate that the difference is statistically significant.*

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Tab11 (Table11)

The table shows the results of a study on the effectiveness of omeprazole for treating GERD. The successful symptomatic outcome was achieved in a higher percentage of patients taking 20mg am omeprazole compared to those taking 10mg omeprazole or placebo. The success rate was even higher for patients with confirmed GERD. Success was defined as complete resolution of heartburn. The results were statistically significant with p values less than 0.005.*

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Tab12 (Table12)

Table 12 shows the percentage of patients healed with Omeprazole 40mg, Omeprazole 20mg, and Placebo at Week 4 and Week 8. The data suggests that both Omeprazole doses were successful in healing patients within 8 weeks, with significant differences in effectiveness between Omeprazole and placebo.*

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Tab13 (Table13)

This is a table presenting the results of a Life Table Analysis comparing the effectiveness of Omeprazole at a dose of 20mg once daily versus 20mg three consecutive days a week and placebo. The number of participants in each group is listed as well as the percentage of them who achieved endoscopic remission after 6 months. There is a significant difference in the results between the Omeprazole daily group and the other groups, with a p-value less than 0.01.*

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Tab14 (Table14)

Table 14 provides results from a life table analysis comparing the effectiveness of Omeprazole 20mg taken once daily and Ranitidine 150mg taken twice daily on endoscopic remission over12 months. The study involved 131 participants taking Omeprazole and 128 taking Ranitidine. The table shows that the percent of those in endoscopic remission was higher for Omeprazole once daily (77%) than Ranitidine (46%). It also indicates that there was a statistically significant difference in endoscopic remission between Omeprazole 20mg and Ranitidine, as well as between Omeprazole 10mg and Ranitidine.*

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Table2 (Table2)

This table shows the adverse reactions that occurred in 1% or more of patients on Omeprazole therapy. The reactions include headache, diarrhea, abdominal pain, nausea, upper respiratory infection, dizziness, vomiting, rash, constipation, cough, asthenia, and back pain. The number of patients experiencing these reactions is also given for the Omeprazole group, the Placebo group, and the Ranitidine group.*

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Table3 (Table3)

This is a table displaying the incidence of adverse reactions caused by Omeprazole and Placebo. The table shows the percentage of patients that suffered from various symptoms such as abdominal pain, asthenia, constipation, diarrhea, flatulence, nausea, vomiting, acid regurgitation, headache, etc. Percentages range from 0 to 67%. No causal relationship was assessed in some cases.*

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Table5 (Table5)

This is a table presenting the effect of Omeprazole and Sodium Bicarbonate Oral Suspension on gastric pH on Day 7. The table compares the effect of two different doses of the suspension on various parameters such as integrated gastric acidity, time gastric pH > 4, and median pH. The values represent medians measured over a 24-hour period. The coefficient of variation for each parameter is also given. The table suggests that the 40mg dose is more effective than the 20mg dose for increasing the time gastric pH>4.*

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Tab6 (Table6)

This is a table that shows the treatment of active duodenal ulcer by comparing the percentage of patients healed using Omeprazole 20mg in the morning and placebo in the morning. The percentage of patients healed is shown in Week 2 and Week 4. According to the results, Omeprazole was more effective in healing patients compared to the placebo. The results are statistically significant (p<0.01).*

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Tab7 (Table7)

Table 7 shows the percentage of patients who were healed after treatment with Omeprazole and Ranitidine for active duodenal ulcer. Omeprazole 20 mg once a day had a higher healing rate compared to Ranitidine 150 mg twice a day at week 4 (82% vs 63%). The difference was statistically significant (p<0.01).*

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Tab8 (Table8)

Table 8 shows the percentage of patients who were healed from active duodenal ulcer using Omeprazole, Ranitidine, and a placebo. The table includes the number of patients for each treatment and the percentage of patients healed at week 2, week 4, and week 8. The results indicate that Omeprazole was the most effective treatment, with all patients healed by week 4. The placebo was the least effective, with only 53% of patients healed at week 2. The significance level of the results is indicated by *(p<0.01).*

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Tab9 (Table9)

Table 9 shows the percentage of patients healed from gastric ulcer using different treatments. The treatments compared were Omeprazole 40 mg q.d., Omeprazole 20 mg q.d., and placebo, and the number of patients treated were 214, 202, and 104 respectively. The table shows the percentage of patients healed after four weeks and eight weeks of treatment. Omeprazole 40 mg q.d. showed better healing rates as compared to Omeprazole 20 mg q.d. and placebo treatments. The results were statistically significant with p<0.01 for Omeprazole 40 mg or 20 mg versus placebo and p<0.05 for Omeprazole 40 mg versus 20mg.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.