Prasugrel Tablet, Film Coated
Product Images NDC 65862-829

10 FDA label images from Aurobindo Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Prasugrel (NDC 65862-829). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1: Non-cabg-related Timi Major Or Minor Bleeding Events. (Prasugrel Fig1)

Figure 1: Non-cabg-related Timi Major Or Minor Bleeding Events. (Prasugrel Fig1)
A line graph comparing the incidence of non-CABG-related TIMI major or minor bleeding events (%) over days from randomization for two drugs, Prasugrel and Clopidogrel. The graph shows a higher bleeding event percentage for Prasugrel through 450 days, with accompanying patient numbers at risk listed below the x-axis. An inset zooms in on the first 7 days with detailed event rates for both drugs.*
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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. (Prasugrel Fig2)

Figure 2: Inhibition (mean±sd) Of 20 μm Adp-induced Platelet Aggregation (ipa) Measured By Light Transmission Aggregometry After Prasugrel 60 mg. (Prasugrel Fig2)
A line graph showing the inhibition of platelet aggregation (%) on the y-axis over time in hours on the x-axis, labeled with mean ± standard deviation at 20 µM ADP concentration. The graph illustrates changes in platelet aggregation inhibition from 0 to 24 hours.*
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Figure 3: Time To First Event Of Cv Death, Mi, Or Stroke (triton-timi 38). (Prasugrel Fig3)

Figure 3: Time To First Event Of Cv Death, Mi, Or Stroke (triton-timi 38). (Prasugrel Fig3)
Two line graphs comparing cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke percentages over days from randomization for Prasugrel and Clopidogrel. The top graph shows data for UA/NSTEMI, and the bottom graph shows STEMI data. Each graph includes smaller inset graphs for early days with p-values indicating statistical significance.*
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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. (Prasugrel Fig4)

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. (Prasugrel Fig4)
A hazard ratio forest plot comparing percent events for Prasugrel versus Clopidogrel across various baseline characteristics such as age groups, gender, body weight, geographic region, diabetes status, metabolic syndrome, previous medical history, time from symptom onset, stent type, and GP IIb/IIIa inhibitor use. The plot visually displays hazard ratios with markers and confidence intervals, indicating relative effectiveness between the two drugs within each subgroup.*
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Figure5 (Prasugrel Fig5)

Figure5 (Prasugrel Fig5)
A forest plot chart showing baseline characteristics and percent events for patients treated with Prasugrel versus Clopidogrel. The chart compares hazard ratios across various subgroups including age, gender, body weight, region, diabetes status, metabolic syndrome, previous medical history (MI, PCI, CABG, TIA/Stroke), time from symptom onset, stent type, and GP IIb/IIIa inhibitor use, indicating relative benefits between the two drugs.*
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Package Label-principal Display Panel (5 mg (30 Tablets Bottle))

Package Label-principal Display Panel (5 mg (30 Tablets Bottle))
Label for Prasugrel Tablets 5 mg film-coated oral tablets by Aurobindo Pharma Limited. The label includes the NDC 65862-829-30 and indicates a package size of 30 tablets. It states that each tablet contains the equivalent of 5 mg prasugrel. Storage instructions, distributor address in East Windsor, NJ, and safety notes are also visible, along with a barcode on the right side.*
FDA Label Image

Package Label-principal Display Panel (5 mg (3 x 10) Unit-dose Tablets)

Package Label-principal Display Panel (5 mg (3 x 10) Unit-dose Tablets)
Prasugrel Tablets 5 mg film-coated oral tablets packaging label from Aurobindo Pharma Limited. The carton contains 30 unit-dose tablets (3 x 10). It includes dosing, storage instructions, and warnings, noting the package is not child-resistant and should be dispensed in the original container. Distributed by Aurobindo Pharma USA, Inc.*
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Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Package Label-principal Display Panel (10 mg (30 Tablets Bottle))
Prasugrel Tablets 10 mg film-coated tablets in a label for a 30-tablet bottle. The label states the active ingredient as prasugrel hydrochloride 10.98 mg equivalent to prasugrel 10 mg. It includes storage instructions, distributor details (Aurobindo Pharma USA, Inc., East Windsor, NJ), and indicates the product is made in India by Aurobindo Pharma Limited. The label also features a barcode and usual dispensing warnings.*
FDA Label Image

Package Label-principal Display Panel (10 mg (3 x 10) Unit-dose Tablets)

Package Label-principal Display Panel (10 mg (3 x 10) Unit-dose Tablets)
Prasugrel Tablets 10 mg film-coated oral tablets in a unit-dose package with 30 tablets (3 x 10). Label states Rx only, not a child-resistant container, and advises keeping and dispensing only in the original container. Distributed by Aurobindo Pharma USA, Inc., made in India. Includes storage instructions and a barcode.*
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Chemical Structure (Prasugrel Str)

Chemical Structure (Prasugrel Str)
Chemical structure of prasugrel hydrochloride, illustrating its molecular framework including a cyclopropyl ketone moiety, thienopyridine ring, fluorophenyl group, and hydrochloride salt form.*

* 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.