Clopidogrel Bisulfate Tablet, Film Coated
Product Images NDC 0615-8625
View Photos of 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 Clopidogrel Bisulfate (NDC 0615-8625). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Ncs Healthcare Of Ky, Llc Dba Vangard Labs, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Principal Display Panel (Clopidogrel Tabs 8625 10)
This is a detailed list of Clopidogrel tablets including various formulations and dosages. It provides information such as product name, strength, lot numbers, expiration date, and storage instructions. The tablets are intended for prescription use only, and the packaging is associated with the trademark of Omnicare, Inc.*
Principal Display Panel (Clopidogrel Tabs 8625 11)
This text appears to be a detailed description of a pharmaceutical product. The product is identified as Clopidogrel, USP 75 mg tablets, manufactured by Vangard Labs in Glasgow, KY. The text includes information on lot numbers, packaging details, store conditions (recommended temperature), expiration date, and dosage instructions. It mentions that each tablet contains Clopidogrel bisulfate, USP, and the item is for prescription use only. The text gives the National Drug Code (NDC) numbers, relevant warnings, and storage instructions. The recommended range for storing the product is between 15°C to 30°C (59°F to 86°F). Users are advised to check the accompanying package insert for full prescribing information.*
Figure1 (Clopidogrel Tabs 8625 2)
This text provides information on the exposure to Clopidogrel Active Metabolite after multiple doses of Clopidogrel 75 mg alone or with Proton Pump Inhibitors (PPIs). It includes a comparison of the effect of co-administered PPIs on the active metabolite area under the curve (AUC) with corresponding mean and 90% confidence interval values. Additionally, it lists specific PPIs like Deslansoprazole, Lansoprazole, Pantoprazole, and Omeprazole along with their respective dosages and their change relative to clopidogrel administered alone.*
Figure3 (Clopidogrel Tabs 8625 3)
This text appears to be discussing the comparison of cardiovascular events such as cardiovascular death, myocardial infarction, and stroke between two groups: one receiving placebo plus aspirin and the other receiving clopidogrel plus aspirin. The cumulative event rates over the course of 12 months are shown, highlighting a statistically significant difference with a p-value of 0.00009. Additionally, it notes the use of other standard therapies as needed.*
Figure3 (Clopidogrel Tabs 8625 4)
The text appears to be a comparison between Clopidogrel and Placebo in different scenarios with corresponding percentages. The data shows the number of cases, percentages for Clopidogrel and Placebo, and highlights the instances where either treatment is favored. The hazard ratio with a 95% confidence interval is also provided for each scenario. This information could be used for evaluating the effectiveness of Clopidogrel compared to Placebo in various situations.*
Figure4 (Clopidogrel Tabs 8625 5)
This description shows the cumulative event rates for death in the COMMIT Study. The data indicates that the placebo group had 1845 deaths (8.1%), while the clopidogrel group had 1726 deaths (7.5%). There was a 7% proportional risk reduction with clopidogrel compared to placebo, with a significance level of p=0.03. All treated patients received aspirin during the study, and the observation period extended up to 28 days post randomization.*
Figure5 (Clopidogrel Tabs 8625 6)
This is a comparison of the placebo and clopidogrel medications concerning the occurrence of events. The placebo group had 2310 events, representing 10.1%, while the clopidogrel group had 2121 events, representing 9.2%, indicating a 9% reduced proportional risk. There was a 7% reduction in deaths with clopidogrel compared to the placebo group (p=0.002). Additionally, the occurrence of re-infarction or stroke was lower in the clopidogrel group before discharge. The data is presented over a period of 28 days since randomization.*
Figure6 (Clopidogrel Tabs 8625 7)
Figure7 (Clopidogrel Tabs 8625 8)
Figure8 (Clopidogrel Tabs 8625 9)
This is a table showing hazard ratios and 95% confidence intervals by baseline subgroups in the CAPRIE study for different conditions such as stroke, MI, and PAD. The comparison is between clopidogrel and aspirin treatments. The results are presented in a format where the hazard ratios for each condition are specified, allowing for an evaluation of the efficacy of the two treatments.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.