Gilenya Capsule
Product Images NDC 0078-0965

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Gilenya (NDC 0078-0965). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novartis Pharmaceuticals Corporation, 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

Fingolimod Chemical Structure (Gilenya 01)

Chemical structure diagram of the active ingredient Fingolimod hydrochloride, showing its molecular arrangement with an ammonium group and chloride ion.*

FDA Label Image

Figure 1 Time To 3-month Confirmed Disability Progression – Study 1 (itt Population) (Gilenya 02)

A Kaplan-Meier curve showing the percentage of patients with three-month confirmed progression over time (days) comparing Gilenya 0.5 mg oral capsules versus placebo. The graph indicates lower progression in the Gilenya group (red solid line) compared to placebo (black dashed line) over a period up to approximately 720 days, with final percentages near 18% for Gilenya and 24% for placebo.*

FDA Label Image

Principal Display Panel Gilenya 0.5 mg 30 Capsules (Gilenya 03)

Gilenya (fingolimod) capsules 0.5 mg oral medication, labeled as equivalent to 0.56 mg fingolimod hydrochloride. The packaging indicates a bottle containing 30 capsules, with instructions to dispense with the enclosed Medication Guide. Manufactured by Novartis Pharma Stein AG, Switzerland, and distributed by Novartis Pharmaceuticals Corporation, East Hanover, NJ.*

FDA Label Image

Principal Display Panel Gilenya 0.25 mg 7 Capsules (Gilenya 04)

Packaging label for Gilenya (fingolimod) capsules 0.25 mg by Novartis Pharmaceuticals Corporation. The label specifies the strength as 0.25 mg, equivalent to 0.28 mg fingolimod hydrochloride. It includes instructions for use, opening and closing instructions for the card, and states that the package contains 7 capsules. The label also features product identifiers such as NDC and GTIN codes.*

* 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.