Razadyne
Product Images NDC 21695-184

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Razadyne (NDC 21695-184). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rebel Distributors Corp, 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

Chemical Structure (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 01)

Chemical structure of galantamine hydrobromide, the active ingredient in RAZADYNE. The structure shows multiple rings including an aromatic ring, and functional groups such as a hydroxyl (OH), a methoxy (CH3O) group, and a methylated nitrogen (N-CH3) with hydrobromide (HBr) association.*

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Graph 1 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 02)

A line graph depicting mean change from baseline in ADAS-cog score over 21 weeks of treatment. The graph includes four lines indicating different groups: placebo, 8 mg/day, 16 mg/day, and 24 mg/day dosages. The y-axis represents the mean change with positive values indicating improvement and negative indicating decline.*

FDA Label Image

Graph 2 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 03)

A cumulative percentage of patients line graph showing ADAS-cog change from baseline, comparing placebo and three doses of a drug (8 mg/day, 16 mg/day, 24 mg/day). The x-axis shows ADAS-cog change from -15 to +15 points, and the y-axis shows cumulative percentage of patients from 0 to 100%. Four vertical lines mark -10, -7, -4 points, and no change.*

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Graph 3 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 04)

A bar chart showing the distribution of CIBIC-plus ratings among patients receiving placebo or Razadyne at 8 mg/day, 16 mg/day, and 24 mg/day. The x-axis categorizes patient responses from markedly improved to markedly worse, while the y-axis indicates the percentage of patients for each rating. Different shading represents each dosage group and placebo.*

FDA Label Image

Graph 4 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 05)

A line graph depicting the mean change from baseline in ADAS-cog scores over 26 weeks of treatment for three groups: Placebo, 24 mg/day, and 32 mg/day. The y-axis represents mean change with positive values indicating decline and negative values indicating improvement. The 24 mg/day and 32 mg/day groups show improvement over time, while the placebo group shows decline.*

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Graph 5 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 06)

A cumulative percentage plot depicting ADAS-cog change from baseline in patients, comparing placebo, 24 mg/day, and 32 mg/day groups of the drug Razadyne. The x-axis shows changes from -15 to 15 in ADAS-cog scores, and the y-axis shows cumulative percentage of patients from 0% to 100%. Lines for each treatment group illustrate shifts in cognitive change, with vertical lines indicating -10, -7, -4 points and no change.*

FDA Label Image

Graph 6 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 07)

A bar chart depicting the percentage of patients by CIBIC-plus Rating categories comparing Placebo, 24 mg/day, and 32 mg/day treatment groups. Categories range from Markedly Improved to Markedly Worse on the x-axis, while the y-axis shows patient percentage. The chart highlights differences in patient responses across treatments.*

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Graph 7 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 08)

Line graph showing mean change from baseline in ADAS-Cog scores over 26 weeks of treatment. The graph compares placebo with two dosage groups, 24 mg/day and 32 mg/day, indicating improvement or decline in cognitive scores with error bars at multiple time points.*

FDA Label Image

Graph 8 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 09)

Cumulative percentage plot showing ADAS-cog change from baseline for RAZADYNE at dosages 24 mg/day and 32 mg/day, compared to placebo. The x-axis represents ADAS-cog change and the y-axis shows cumulative percentage of patients. Markers indicate placebo, 24 mg/day, and 32 mg/day dose groups.*

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Graph 9 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 10)

A bar chart showing the percentage of patients by CIBIC-plus rating categories comparing placebo, 24 mg/day, and 32 mg/day doses. Categories include Markedly Improved, Moderately Improved, Minimally Improved, No Change, Minimally Worse, Moderately Worse, and Markedly Worse, with corresponding patient percentages on the y-axis.*

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Graph 10 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 11)

Line graph showing mean change from baseline in ADAS-cog score over 13 weeks of treatment comparing RAZADYNE at 24 or 32 mg/day versus placebo. The vertical axis indicates improvement and decline, with RAZADYNE showing greater improvement over time compared to placebo.*

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Graph 11 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 12)

A cumulative percentage graph depicting patient response to Razadyne compared to placebo based on ADAS-cog change from baseline. The x-axis measures change in ADAS-cog scores, and the y-axis shows cumulative percentage of patients. The graph includes markers for placebo and Razadyne 24 or 32 mg/day dosage.*

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Graph 12 (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 13)

Bar chart comparing the percentage of patients by CIBIC-plus rating categories between placebo and 24 or 32 mg/day dosing groups for RAZADYNE. Categories range from Markedly Improved to Markedly Worse, showing distributions of patient responses.*

FDA Label Image

Razadyne Hbr 4mg (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 14)

Razadyne HBr 4 mg tablets packaging label showing a quantity of 30 tablets. The label includes the Physician Partner logo and details such as NDC 21695-184-30, lot number, expiration date, and product ID PR018430. It specifies that each tablet contains 4 mg galantamine equivalent and is marked RX only. The label also states the manufacturer as Ortho-McNeil Neurologicals, Inc. and packaging by Physician Partner, Thousand Oaks, CA.*

FDA Label Image

Razadyne 12mg (Ea6968e3 6383 4ff1 8c81 E4a2fdfe749d 15)

The label is for Razadyne 12 mg tablets, quantity 30, distributed by Rebel Distributors Corp. It includes active ingredient information stating each tablet contains 12 mg Galantamine equivalent to 13.3 mg Galantamine HBr. The label shows Directions for Use and storage instructions indicating controlled room temperature. The label includes Physician Partner branding and various barcodes.*

* 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.