Difluprednate Emulsion
Product Images NDC 69315-329

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Difluprednate (NDC 69315-329). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Leading Pharma, 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

Cartonlabel (Cartonlabel)

Packaging label for Difluprednate Ophthalmic Emulsion 0.05%, 5 mL vial, from Leading Pharma, LLC. The label includes the NDC 69315-329-05, directions that it is for eye use only, sterile, and prescription-only. It lists active ingredient strength as 0.5 mg/mL and includes manufacturer Caplin Steriles Limited, India, batch printing information area, and storage instructions.*

FDA Label Image

Chemicalstructure (Chemstruc)

Chemical structure of Difluprednate, showing its steroid backbone with fluorine substitutions and ester groups, as depicted in the image.*

FDA Label Image

Containerlabel (Containerlabel)

Label for Difluprednate Ophthalmic Emulsion 0.05%, a prescription eye emulsion containing 0.5 mg/mL of difluprednate. The sterile 5 mL bottle is labeled for eye use only, manufactured by Caplin Steriles Limited and distributed by Leading Pharma, LLC. It includes storage instructions, NDC 69315-329-05, and a barcode.*

FDA Label Image

Fig1 (Fig1)

A bar graph titled 'Percent of Subjects with Anterior Chamber Cells Clearing (Cell Count = 0)' comparing Difluprednate ophthalmic emulsion 0.05% QID and placebo at Day 8 and Day 15. The y-axis shows percentage from 0 to 100%, with Difluprednate showing higher clearing percentages (22% at Day 8, 41% at Day 15) compared to placebo (8% at Day 8, 12% at Day 15). Asterisks indicate statistically significant differences (P<0.05).*

FDA Label Image

Fig2 (Fig2)

A bar chart titled 'Percent of Subjects who were Pain Free' showing comparative percentages over Days 3, 8, and 15. It compares Difluprednate ophthalmic emulsion 0.05% QID (n=107) and placebo (n=220) groups, with Difluprednate consistently showing higher pain-free percentages. Statistical significance (P<0.05) is indicated for Difluprednate at each time point.*

* 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.