Nuedexta Capsule, Gelatin Coated
Product Images NDC 59148-053

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Nuedexta (NDC 59148-053). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Otsuka America Pharmaceutical, Inc, 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

The Structural Formula For Dextromethorphan Hydrobromide Is The Pharmacologically Active Ingredient Of Nuedexta That Acts On The Central Nervous System (cns). The Chemical Name Is Dextromethorphan Hydrobromide: Morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), Hydrobromide Monohydrate. Dextromethorphan Hydrobromide Has The Empirical Formula C18h25no•hbr•h2o With A Molecular Weight Of 370.33. (Nuedexta 01)

Chemical structure of dextromethorphan hydrobromide monohydrate, showing the molecular arrangement including a bicyclic framework and a methoxy-substituted aromatic ring, accompanied by the HBr and H2O components.*

FDA Label Image

The Structural Formula For Quinidine Sulfate Is A Specific Inhibitor Of Cyp2d6-dependent Oxidative Metabolism Used In Nuedexta To Increase The Systemic Bioavailability Of Dextromethorphan. The Chemical Name Is Quinidine Sulfate: Cinchonan-9-o1, 6’-methoxy-, (9s) Sulfate (2:1), (salt), Dihydrate. Quinidine Sulfate Dihydrate Has The Empirical Formula Of (c20h24n2o2)2•h2so4•2h2o With A Molecular Weight Of 782.96. (Nuedexta 02)

Chemical structure of dextromethorphan hydrobromide as shown in the image, with associated sulfate and water molecules indicated. The diagram depicts the molecular arrangement with carbon, hydrogen, nitrogen, and oxygen atoms.*

FDA Label Image

Figure 1: Mean Pba Episode Rates By Visit (Nuedexta 03)

A line graph comparing mean change from baseline in laughing and crying episodes over multiple visits between Nuedexta 20/10 and placebo groups. The graph shows a greater reduction in episodes for Nuedexta with statistically significant differences indicated at several time points up to Day 84 (Visit 5).*

FDA Label Image

Figure 2: Least Square Mean Cns-ls Scores By Visit (Nuedexta 04)

A line graph depicting the least square mean change from baseline CNS-LS score over time for Nuedexta 20/10 mg compared to placebo. The x-axis shows different study visits (Baseline to Day 84), and the y-axis represents the score change. Nuedexta shows a greater decrease, with statistically significant differences indicated at Day 57 and Day 84 (p < 0.05).*

FDA Label Image

Principal Display Panel (60 Capsule Bottle Label)

Nuedexta 20 mg/10 mg gelatin coated capsules label. The label shows the dosage strength of dextromethorphan hydrobromide and quinidine sulfate, with a 60 capsule count. It includes storage instructions, manufacturer details for Otsuka America Pharmaceutical, Inc, and a barcode on the right side.*

* 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.