Nuedexta Capsule, Gelatin Coated
Product Images NDC 64597-301

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Nuedexta (NDC 64597-301). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avanir Pharmaceuticals, 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 diagram depicting the molecular formula of dextromethorphan hydrobromide monohydrate, an active ingredient in NUEDEXTA capsules. The structure includes detailed bonding and arrangement of atoms including the hydrobromide and water 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 diagram of dextromethorphan hydrobromide sulfate dihydrate, illustrating the molecular arrangement including aromatic rings, methoxy group, and ethyl side chains, with accompanying sulfate and water molecule notation.*

FDA Label Image

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

Line graph showing the mean change from baseline in laughing and crying episodes over multiple visits for NUEDEXTA 20/10 mg compared to placebo. The graph indicates values at baseline and visits on days 15, 29, 57, and 84, with statistically significant differences marked for NUEDEXTA at several time points compared to placebo.*

FDA Label Image

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

A line graph comparing the least square mean change from baseline CNS-LS score over five visits between NUEDEXTA 20/10 and placebo groups. The vertical axis shows score change, and the horizontal axis marks visits from baseline to Day 84. NUEDEXTA shows a greater decrease in CNS-LS score, with statistically significant differences at Days 57 and 84.*

FDA Label Image

Principal Display Panelndc 64597-301-60nuedexta(dextromethorphan Hbr And Quinidine Sulfate) Capsules20 mg/ 10 mg60 Capsulesrx Only (Nuedexta 05)

NUEDEXTA capsules label showing the product name and active ingredients, dextromethorphan hydrobromide and quinidine sulfate, with strengths of 20 mg and 10 mg respectively. The label indicates the package contains 60 capsules and is marked Rx only. It includes manufacturer information for Avanir Pharmaceuticals, Inc., storage instructions, dosage reminder, and contact details for questions or comments.*

FDA Label Image

Nuedexta 06

Carton packaging label for NUEDEXTA 20 mg/10 mg gelatin-coated capsules containing dextromethorphan hydrobromide and quinidine sulfate. The label indicates professional sample status, Rx only, and contains 13 capsules. The product is labeled by Avanir Pharmaceuticals, Inc., and includes storage instructions and a barcode.*

* 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.