Prasugrel Tablet, Film Coated
Product Images NDC 0378-5186

8 FDA label images from Mylan Pharmaceuticals Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Prasugrel (NDC 0378-5186). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Pharmaceuticals Inc., 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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Figure 1: Non-cabg-related Timi Major Or Minor Bleeding Events. (Image 01)

Figure 1: Non-cabg-related Timi Major Or Minor Bleeding Events. (Image 01)
A line graph comparing the percentage of non-CABG-related TIMI major or minor bleeding events over time in days between Prasugrel tablets and Clopidogrel. The main graph shows data up to 450 days with Prasugrel consistently higher than Clopidogrel. An inset graph zooms in on the first 7 days post-randomization, showing a similar trend with Prasugrel exceeding Clopidogrel in bleeding events.*
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Prasugrel Hydrochloride Structural Formula (Image 02)

Prasugrel Hydrochloride Structural Formula (Image 02)
Chemical structure of Prasugrel hydrochloride, depicted as a 2D molecular diagram showing its distinct rings and functional groups including a fluorophenyl group, cyclopropyl ketone, piperidine ring, thienopyridine, and an ester moiety.*
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Figure 2: Inhibition (mean ± Sd) Of 20 μm Adp-induced Platelet Aggregation (ipa) Measured By Light Transmission Aggregometry After Prasugrel 60 mg. (Image 03)

Figure 2: Inhibition (mean ± Sd) Of 20 μm Adp-induced Platelet Aggregation (ipa) Measured By Light Transmission Aggregometry After Prasugrel 60 mg. (Image 03)
A line graph depicting the inhibition of platelet aggregation (%) over time (hours) following administration of 20 µM ADP. The graph displays mean values with standard deviations, showing a sharp increase in inhibition within the first 2 hours, followed by a plateau up to 24 hours.*
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Figure 3: Time To First Event Of Cv Death, Mi, Or Stroke (triton-timi 38). (Image 04)

Figure 3: Time To First Event Of Cv Death, Mi, Or Stroke (triton-timi 38). (Image 04)
Two Kaplan-Meier plots comparing cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke over time (days from randomization) between Prasugrel tablets and Clopidogrel in patients with UA/NSTEMI and STEMI. Separate inset graphs show early time periods with corresponding p-values indicating statistical significance of differences between treatments.*
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Figure 4: Subgroup Analyses For Time To First Event Of Cv Death, Mi, Or Stroke (hr And 95% Ci; Triton-timi 38) – Ua/nstemi Patients. (Image 05)

Figure 4: Subgroup Analyses For Time To First Event Of Cv Death, Mi, Or Stroke (hr And 95% Ci; Triton-timi 38) – Ua/nstemi Patients. (Image 05)
A forest plot chart displaying baseline characteristics and percent event rates comparing Prasugrel tablets to Clopidogrel. Variables include age, gender, body weight, region, diabetes status, metabolic syndrome, previous myocardial infarction, PCI, CABG, stroke/TIA history, time from symptom onset, stent type, and GP IIb/IIIa inhibitor usage. Hazard ratios with confidence intervals indicate relative risk favoring Prasugrel or Clopidogrel.*
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Figure 5: Subgroup Analyses For Time To First Event Of Cv Death, Mi, Or Stroke (hr And 95% Ci; Triton-timi 38) – Stemi Patients. (Image 06)

Figure 5: Subgroup Analyses For Time To First Event Of Cv Death, Mi, Or Stroke (hr And 95% Ci; Triton-timi 38) – Stemi Patients. (Image 06)
A forest plot displaying baseline characteristics and hazard ratios comparing percent events between Prasugrel and Clopidogrel tablets at 10 mg strength. The plot includes variables such as age, gender, body weight, region, diabetes status, metabolic syndrome, previous cardiovascular events, time from symptom onset, stent type, and GP IIb/IIIa inhibitor use. The horizontal axis shows hazard ratios indicating relative effectiveness between the two treatments.*
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Prasugrel Tablets 5 mg Bottle Label (Image 07)

Prasugrel Tablets 5 mg Bottle Label (Image 07)
Prasugrel 5 mg film-coated tablets label from Mylan Pharmaceuticals Inc. The label includes dosage strength, tablet image, storage instructions, and warnings to keep the container closed and medication out of reach of children. The package contains 30 tablets with pharmacist dispensing instructions and barcode details.*
FDA Label Image

Prasugrel Tablets 10 mg Bottle Label (Image 08)

Prasugrel Tablets 10 mg Bottle Label (Image 08)
Label for Prasugrel film-coated tablets, USP 10 mg, manufactured by Mylan Pharmaceuticals Inc. The label indicates the product is for oral use, prescription only, with a package of 30 tablets. It includes storage instructions, warnings to keep out of reach of children, and a note to dispense the medication guide to patients. The label features the NDC 0378-5186-93 barcode and manufacturer details.*

* 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.