Precedex Injection, Solution, Concentrate
Product Images NDC 0404-9938

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Precedex (NDC 0404-9938). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Henry Schein, 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

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Chemical structure of dexmedetomidine hydrochloride depicted as a two-dimensional molecular diagram showing atom connectivity, including an imidazole ring and aromatic components, with the hydrochloride salt indicated.*

FDA Label Image

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Table titled 'Ramsay Level of Sedation Scale' presenting clinical scores from 1 to 6 alongside corresponding levels of sedation achieved, ranging from anxious and restless to asleep with no response.*

FDA Label Image

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A data table titled 'Midazolam Use as Rescue Medication During Intubation (ITT) Study One' comparing placebo and Precedex groups. It presents mean total dose of midazolam (mg) with standard deviation and categorized midazolam use in mg, including sample sizes. Statistical values such as p-values and notes on ANOVA and Chi-square tests are included.*

FDA Label Image

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A clinical data table titled 'Propofol Use as Rescue Medication During Intubation (ITT) Study Two' comparing Propofol dosages between Placebo (N=198) and Precedex (N=203) groups. It presents mean total doses, standard deviations, and categorized Propofol usage percentages with associated p-values, statistical tests noted as ANOVA and Chi-square.*

FDA Label Image

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Table titled 'Observer's Assessment of Alertness/Sedation' showing assessment categories including Responsiveness, Speech, Facial Expression, Eyes, and Composite Score. The table details different levels of alertness from fully responsive with normal speech and facial expression to deep sleep with no response, including descriptions of speech changes, facial relaxation, and eye conditions at each responsiveness level.*

FDA Label Image

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A data table titled 'Key Efficacy Results of Procedural Sedation Studies' presenting clinical study results comparing dexmedetomidine at different dosages versus placebo. It includes columns for study arms, number of patients enrolled, percentage not requiring midazolam rescue, confidence intervals on difference vs. placebo, and mean total dose of midazolam rescue required, with statistical confidence intervals provided.*

FDA Label Image

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A table listing a single National Drug Code (NDC) number 0409-1638-02 associated with a vial container of size 2 mL.*

FDA Label Image

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Table listing NDC numbers associated with containers and sizes for PRECEDEX, showing vial and bottle types with volumes ranging from 20 mL to 250 mL.*

FDA Label Image

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Label for PRECEDEX (Dexmedetomidine Hydrochloride) injection, solution concentrate, 100 mcg/mL strength in a 2 mL single-dose vial. The label states intravenous use with dilution required, preservative-free formulation, and storage instructions at controlled room temperatures. Henry Schein, Inc. is listed as the packager at Bastian, VA.*

* 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.