Riluzole Tablet, Film Coated
Product Images NDC 69076-200

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Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Riluzole (NDC 69076-200). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Florida Pharmaceutical Products, 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.

Product Images & Figures Index

FDA Label Image

Image Description (Manufacturer Info)

Image Description (Manufacturer Info)
This is a product manufactured by Quinn Pharmaceuticals for which contact information is provided. The product was manufactured by Standard Chem. & Pharm. Co., Ltd. in Taiwan.*
FDA Label Image

Chemical-structure-riluzole (Spl Image 1 Structure)

Chemical-structure-riluzole (Spl Image 1 Structure)
FDA Label Image

Figure1 (Spl Image 2 Figure 1)

Figure1 (Spl Image 2 Figure 1)
FDA Label Image

Figure2 (Spl Image 3 Figure 2)

Figure2 (Spl Image 3 Figure 2)
FDA Label Image

Label (Spl Image 4 Label)

Label (Spl Image 4 Label)
The description is for Riluzole 50mg tablets. Each tablet contains 50g of USP and should be taken orally every 12 hours. The prescription should be taken as directed. There is a caution to keep the medication fresh and protect it from high temperatures. There is further information about the manufacturer and contact details.*
FDA Label Image

Table1 (Table1)

Table1 (Table1)
This is a comparison of side effects in two groups of people. One group was given Riluzole Tablets of 50mg, twice daily (N=313), and the other group was given a placebo (N=320). The table lists various side effects experienced by participants in both groups, such as asthenia, nausea, hypertension, decreased lung function, and abdominal pain. The percentage of people experiencing each side effect is listed.*
FDA Label Image

Table2 (Table2)

Table2 (Table2)
This is a table showing pharmacokinetic parameters of riluzole, a drug used for the treatment of amyotrophic lateral sclerosis (ALS). The drug has an oral bioavailability of approximately 60% and is linear over a dose range of 25 mg to 100 mg. The absorption of the drug is affected by food, resulting in a 20% increase in AUC and a 45% increase in Cmax when taken with a high-fat meal. The drug is highly protein-bound (96%), mainly to albumin and lipoproteins. The elimination half-life is approximately 12 hours, and there is high interindividual variability in the clearance of riluzole, potentially attributable to variability in CYP1A2. The primary elimination pathway for the drug is through the urine (80%), with 2% unchanged riluzole. The drug is metabolized through oxidation and direct and sequential glucuronidation, with at least 88% of the dose being metabolized. Some metabolites of the drug appear pharmacologically active in vitro, but the clinical implications are not known.*

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