Clopidogrel Bisulfate
Product Images NDC 43353-269

12 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · 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 Clopidogrel Bisulfate (NDC 43353-269). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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.

FDA Label Image

Bottle Label 75mg (43353 269)

Bottle Label 75mg (43353 269)
Clopidogrel Bisulfate 75 mg tablets packaging label showing a bottle containing 90 tablets. The label includes the proprietary name Clopidogrel Bisulfate, strength of 75 mg, quantity of 90 tablets, and indicates it is for prescription use only (RX Only). It is labeled by Aphena Pharma Solutions - Tennessee, LLC in Webston, Ontario.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure3 (Figure3)

Figure3 (Figure3)
A figure showing hazard ratios for patient baseline characteristics and on-study concomitant medications/interventions in the CURE study for clopidogrel bisulfate, comparing clopidogrel and placebo groups across subgroups by age, gender, race, elevated cardiac enzymes, diabetes, previous myocardial infarction, and previous stroke.*
FDA Label Image

Figure3b (Figure3b)

Figure3b (Figure3b)
A forest plot titled 'Hazard Ratio for Patient Baseline Characteristics and On-Study Concomitant Medications/Interventions for the CURE Study (continued),' comparing hazard ratios for clopidogrel bisulfate versus placebo across various subgroups including Heparin/LMWH use, Aspirin dosage, GPIIb/IIIa antagonist use, Beta-Blocker use, and Ace Inhibitor use. The plot displays hazard ratios with 95% confidence intervals and numerical counts for each subgroup, visually showing the relative hazard favoring either clopidogrel or placebo.*
FDA Label Image

Figure6 (Figure6)

Figure6 (Figure6)
A chart titled 'Effects of Adding Clopidogrel to Aspirin on the Combined Primary Endpoint' from the COMMIT study. It shows odds ratios with 99% confidence intervals comparing Clopidogrel to placebo across subgroups based on gender, age, hours since onset, systolic blood pressure, heart rate, and fibrinolytic agent use. Data points and confidence intervals are plotted visually on a horizontal axis ranging from 0.6 to 1.3.*
FDA Label Image

Figure7 (Figure7)

Figure7 (Figure7)
A line graph showing cumulative event rates (%) of fatal or non-fatal vascular events over months of follow-up for aspirin and clopidogrel groups in the CAPRIE study. The x-axis represents months of follow-up up to 36 months, and the y-axis shows cumulative event rate up to 16%. The graph compares event rates between aspirin and clopidogrel, with a reported p-value of 0.045.*
FDA Label Image

Chemical Structure-clopidogrel (Clopiodgrel 01)

Chemical Structure-clopidogrel (Clopiodgrel 01)
Chemical structure diagram showing the molecular formula of clopidogrel bisulfate, including a bicyclic thienopyridine ring, a chlorophenyl group, an ester moiety, and a bisulfate component.*
FDA Label Image

Figure-01 (Figure 01)

Figure-01 (Figure 01)
A forest plot illustrating the effect of co-administered proton pump inhibitors (Dexlansoprazole 60 mg, Lansoprazole 30 mg, Pantoprazole 80 mg, Omeprazole 80 mg) on the active metabolite AUC of Clopidogrel 75 mg. The graph shows mean values with 90% confidence intervals representing change relative to Clopidogrel administered alone.*
FDA Label Image

Figure 2 (Figure2)

Figure 2 (Figure2)
A line graph titled 'Cardiovascular Death, Myocardial Infarction, and Stroke in the CURE Study' showing cumulative event rate (%) on the Y-axis and months of follow-up (0 to 12) on the X-axis. Two lines compare placebo (+ aspirin) versus clopidogrel (+ aspirin) groups, with the placebo group showing a higher event rate over time. A p-value of 0.00009 is displayed, indicating statistical significance.*
FDA Label Image

Figure4 (Figure4)

Figure4 (Figure4)
A cumulative event rate graph depicting percentage of death before first discharge over 28 days since randomization from the COMMIT study. It compares placebo and clopidogrel groups, showing separate curves and death counts with a noted 7% proportional risk reduction (p=0.03) for clopidogrel versus placebo.*
FDA Label Image

Figure5 (Figure5)

Figure5 (Figure5)
A cumulative event rate graph from the COMMIT study illustrating the combined endpoints of re-infarction, stroke, or death over 28 days after randomization. The y-axis represents the percentage with these events before first discharge, with two lines comparing placebo and clopidogrel, showing 10.1% events for placebo and 9.2% for clopidogrel, indicating a 9% proportional risk reduction.*
FDA Label Image

Figure8 (Image 01)

Figure8 (Image 01)
A figure titled 'Hazard Ratio and 95% CI by Baseline Subgroups in the CAPRIE Study' showing a horizontal hazard ratio plot comparing clopidogrel and aspirin across subgroups: Stroke, MI, PAD, and Overall. The x-axis ranges from 0.6 to 1.3 with markers indicating hazard ratios and confidence intervals favoring clopidogrel or aspirin. Quantitative data for Clopidogrel and Aspirin groups by subgroup are included in a table format alongside the plot.*

* 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.