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)

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)

FDA Label Image

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)

This appears to be a table or chart displaying information about a statistical analysis of "Least Square Mean Change from Baseline CNS-LS Score" for a medication called "NUEDEXTA" over several days of visits. There are symbols and letters that cannot be interpreted, but there are statistically significant results indicated at a certain level of significance. Without further context, it is unclear what this information may mean or how it should be interpreted.*

FDA Label Image

Principal Display Panel (60 Capsule Bottle Label)

NUEDEXTA is a prescription medication that contains 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate per capsule. It is used as directed by a healthcare provider, and dosage instructions can be found in the package insert. It should be stored at 77°F (26°C), with excursions between 59°F-86°F (15°C-30°C) permitted as long as it is protected from light and moisture. NUEDEXTA is distributed by Otsuka America Pharmaceutical, Inc. The product has a GTIN of 0035148000000, an SN of 100000000001, an expiration date of MMAYYYY, and a unique lot number XXXXXXXX.*

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