Difluprednate Emulsion
Product Images NDC 65145-161

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Difluprednate (NDC 65145-161). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Caplin Steriles 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
FDA Label Image

Difluprednate-carton-5ml (Difluprednate Carton 5ml)

Difluprednate-carton-5ml (Difluprednate Carton 5ml)
Difluprednate Ophthalmic Emulsion 0.05% packaging label for a 5 mL bottle. The label shows the drug as Rx only, sterile, for eye use only, and distributed by Caplin Steriles USA Inc. The label includes ingredient details, storage instructions, and a barcode. Label dimensions and a batch overprinting area are also indicated.*
FDA Label Image

Difluprednate-container-5ml (Difluprednate Container 5ml)

Difluprednate-container-5ml (Difluprednate Container 5ml)
Label for Difluprednate Ophthalmic Emulsion 0.05%, a sterile eye drop emulsion in a 5 mL container. The label indicates the active ingredient concentration is 0.5 mg per mL. It includes storage instructions to keep at controlled room temperature (20°C to 25°C) and avoid freezing and light exposure. The product is distributed by Caplin Steriles USA Inc., Hamilton, NJ.*
FDA Label Image

Fig-1 (Difluprednate Figure 1)

Fig-1 (Difluprednate Figure 1)
A bar chart showing the percent of subjects with anterior chamber cells clearing (cell count = 0) on Days 8 and 15 for Difluprednate ophthalmic emulsion 0.05% QID and placebo groups. Difluprednate shows higher clearance percentages at both time points (22% vs. 8% on Day 8, 41% vs. 12% on Day 15), with statistically significant differences (P < 0.05) indicated.*
FDA Label Image

Fig-2 (Difluprednate Figure 2)

Fig-2 (Difluprednate Figure 2)
A bar chart titled "Percent of Subjects who were Pain Free" comparing Difluprednate ophthalmic emulsion 0.05% QID (n=107) and placebo (n=220) on Days 3, 8, and 15. The vertical axis represents percent from 0 to 100, showing higher percentages for Difluprednate at each time point (45%, 58%, 63%) compared to placebo (25%, 27%, 35%). Significant differences (P<0.05) are indicated on each day for the treatment group.*
FDA Label Image

Difluprednate-structure (Difluprednate Structure)

Difluprednate-structure (Difluprednate Structure)
Chemical structure of difluprednate, displaying the molecular framework and functional groups of the active ingredient used in the ophthalmic emulsion product by Caplin Steriles Limited.*

* 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.