Difluprednate Emulsion
Product Images NDC 69238-1380

5 FDA label images from Amneal Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Difluprednate (NDC 69238-1380). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals 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

1 (Difluprednate Ophthalmic Emulsion 1)

1 (Difluprednate Ophthalmic Emulsion 1)
Chemical structure diagram of the active ingredient Difluprednate, illustrating its molecular framework with labeled stereochemistry and functional groups.*
FDA Label Image

1 (Difluprednate Ophthalmic Emulsion 2)

1 (Difluprednate Ophthalmic Emulsion 2)
Bar chart showing the percent of subjects with anterior chamber cells clearing (cell count=0) comparing Difluprednate ophthalmic emulsion 0.5 mg/mL taken QID (n=107) to placebo (n=220) on Days 8 and 15. Difluprednate shows higher clearing percentages (22% on Day 8, 41% on Day 15) compared to placebo (8% on Day 8, 12% on Day 15). Statistical significance indicated by P<0.05.*
FDA Label Image

1 (Difluprednate Ophthalmic Emulsion 3)

1 (Difluprednate Ophthalmic Emulsion 3)
A bar graph comparing the percent of subjects who were pain free over time between Difluprednate ophthalmic emulsion (0.5 mg/mL) and placebo groups. The graph shows results for Day 3, Day 8, and Day 15, with higher pain-free percentages in the Difluprednate group at each time point, marked with statistical significance (P<0.05).*
FDA Label Image

1 (Difluprednate Ophthalmic Emulsion 4)

1 (Difluprednate Ophthalmic Emulsion 4)
Label for Difluprednate Ophthalmic Emulsion 0.05%, 5 mL sterile eye drops for ophthalmic use. Contains 0.05% Difluprednate per mL. Manufactured by Amneal Pharmaceuticals LLC, Bridgewater, NJ. Includes storage instructions: store at 15° to 25°C (59° to 77°F), do not freeze, and protect from light. Rx only.*
FDA Label Image

1 (Difluprednate Ophthalmic Emulsion 5)

1 (Difluprednate Ophthalmic Emulsion 5)
Label for Difluprednate Ophthalmic Emulsion 0.05%, a sterile ophthalmic emulsion for eye use only. The 5 mL box is labeled for prescription use and produced by Amneal Pharmaceuticals LLC. The label includes active ingredient, preservative, and inactive ingredients, storage instructions, and manufacturing details from Amneal Pharmaceuticals Pvt. Ltd. in India, with distribution in Bridgewater, NJ.*

* 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.