Nuedexta Capsule, Gelatin Coated
Product Images NDC 64597-301

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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.

Product Images & Figures Index

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)

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)
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)

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)
FDA Label Image

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

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

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

Figure 2: Least Square Mean Cns-ls Scores By Visit (Nuedexta 04)
The text appears to be from a clinical study or trial comparing the medication NUEDEXTA to a placebo. It includes some numerical data from days 15 and 20 of the trial and mentions statistical significance.*
FDA Label Image

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

Principal Display Panelndc 64597-301-60nuedexta(dextromethorphan Hbr And Quinidine Sulfate) Capsules20 mg/ 10 mg60 Capsulesrx Only (Nuedexta 05)
NUEDEXTA is a medication in capsule form containing dextromethorphan HBr and quinidine sulfate used for the treatment of pseudobulbar affect (PBA). If you have any questions or comments about this medicine, you can call 1-655-458-3339. The usual dosage information can be found inside the package. The medication is manufactured and distributed by AV Pharmaceuticals, Inc. and should be kept out of the reach of children. Store the capsules at room temperature between 50°F-86°F. The product is copyrighted by Pharmaceuticals and is marked with the AVANIR trademark.*
FDA Label Image

Nuedexta 06

Nuedexta 06

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