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)
This text is a product label for an ophthalmic emulsion called Difluprednate, manufactured in India and distributed by Caplin Steriles USA Inc. The emulsion is indicated for eye use only and contains difluprednate as the active ingredient. The product comes in a 5mL bottle and should be stored at 20°C to 25°C. The label also includes information about the inactive ingredients, preservative, dosage instructions, and packaging details.*
FDA Label Image

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

Difluprednate-container-5ml (Difluprednate Container 5ml)
This product is an ophthalmic emulsion with difluprednate 0.5mg (0.05%) as the active ingredient. It is intended for eye use only and should be stored at room temperature (20-25°C) and protected from light. For detailed usage instructions and prescribing information, refer to the package insert. Distributed by Caplin Steriles USA Inc.*
FDA Label Image

Fig-1 (Difluprednate Figure 1)

Fig-1 (Difluprednate Figure 1)
This text provides information on the percentage of subjects with anterior chamber cells clearing (cell count = 0) after treatment. The study shows that 100% of subjects achieved this clearance by day 15. The treatment group received Difluprednate ophthalmic emulsion 0.05% four times a day, while the placebo group comprised 220 participants. Statistical analysis showed a significant difference between the two groups with a p-value of less than 0.05.*
FDA Label Image

Fig-2 (Difluprednate Figure 2)

Fig-2 (Difluprednate Figure 2)
This description states the percentage of subjects who were pain-free after using Difluprednate ophthalmic emulsion 0.05% four times a day for a specified period. It also compares the results with a placebo group and highlights a statistically significant difference (P<0.05). The study appears to have been conducted over multiple days, with Day 3, Day 5, and Day 15 mentioned in the results.*
FDA Label Image

Difluprednate-structure (Difluprednate Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.