Brexpiprazole Tablet
Product Images NDC 27241-204

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Brexpiprazole (NDC 27241-204). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ajanta Pharma Usa 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

0.25mg (Brexpiprazole 0 25mg)

Label for Brexpiprazole Tablets 0.25 mg, showing a package containing 30 tablets. The label includes the National Drug Code (NDC) 27241-204-30 and is marketed by Ajanta Pharma USA Inc. The label instructs pharmacists to dispense an accompanying medication guide and features storage information and a child-resistant warning.*

FDA Label Image

0.5mg (Brexpiprazole 0 5mg)

Brexpiprazole 0.5 mg tablets label for oral use, containing 30 tablets. The label states the product is marketed by Ajanta Pharma USA Inc., Bridgewater, NJ, and made in India. It includes dosing warnings, storage instructions, and a pharmacist dispensing instruction. The label displays NDC 27241-205-30 and a barcode.*

FDA Label Image

1mg (Brexpiprazole 1mg)

Label for Brexpiprazole Tablets 1 mg, oral dosage form, containing 30 tablets. The label shows the drug name, strength, count, and states the product is for prescription use only. It is marketed by Ajanta Pharma USA Inc. Storage instructions and a warning to keep out of reach of children are included. The label also features a barcode and a designated area for lot and expiration information.*

FDA Label Image

2mg (Brexpiprazole 2mg)

Label for Brexpiprazole Tablets 2 mg, 30 count, by Ajanta Pharma USA Inc. The label includes dosing warnings, storage instructions, and a barcode. It specifies that each film-coated tablet contains 2 mg of brexpiprazole and advises keeping the tablets out of reach of children.*

FDA Label Image

3mg (Brexpiprazole 3mg)

Packaging label for Brexpiprazole Tablets 3 mg oral tablets, 30 count, marketed by Ajanta Pharma USA Inc. The label includes a warning to keep out of reach of children, storage instructions, and a pharmacist note to dispense the accompanying medication guide. The label also shows barcoding and a designated area for lot and expiration dates.*

FDA Label Image

4mg (Brexpiprazole 4mg)

Label for Brexpiprazole Tablets 4 mg, oral dosage form, with a package count of 30 tablets. The label includes storage instructions, a warning to keep out of reach of children, and pharmacist dispensing guidance. It is marketed by Ajanta Pharma USA Inc., made in India, and bears an NDC of 27241-209-30.*

FDA Label Image

Figure1 (Brexpiprazole Figure1)

A pharmacokinetic (PK) chart showing fold change and 90% confidence intervals for Brexpiprazole under different conditions of renal and hepatic impairment, as well as population descriptions by gender and age. The chart plots changes relative to reference values for Cmax and AUCinf measures across severe, moderate, and mild impairment groups, and demographic comparisons between female vs male and elderly vs adult subjects.*

FDA Label Image

Figure2 (Brexpiprazole Figure2)

A pharmacokinetic fold change graph showing the effect of various inhibitors and an inducer on Brexpiprazole plasma levels. Changes in Cmax and AUCinf are plotted with 90% confidence intervals for CYP3A4 Inhibitor (Ketoconazole), CYP2D6 Inhibitor (Quinidine), CYP3A4 Inducer (Rifampin), CYP2B6 Inhibitor (Ticlopidine), and gastric pH increase (Omeprazole) relative to reference without interacting drug.*

FDA Label Image

Figure3 (Brexpiprazole Figure3)

A pharmacokinetic effect chart showing fold change and 90% confidence intervals for various drug substrates metabolized by enzymes CYP2D6, PgP, CYP2B6, CYP3A4, and BCRP. The X-axis indicates change relative to reference without interacting drug, with analytes including dextromethorphan, fexofenadine, bupropion, hydroxy bupropion, lovastatin, lovastatin hydroxy acid, and rosuvastatin, and measures of Cmax and AUCinf.*

FDA Label Image

Figure4 (Brexpiprazole Figure4)

A line graph showing change from baseline over 6 weeks comparing ADT+Placebo and ADT+Brexpiprazole 2 mg. The y-axis represents change from baseline, decreasing from 0 to -12, and the x-axis represents time in weeks from 0 to 6. Two lines show greater decrease with ADT+Brexpiprazole 2 mg compared to ADT+Placebo over the study period.*

FDA Label Image

Figure5 (Brexpiprazole Figure5)

A line graph showing the change from baseline over 6 weeks comparing placebo, 2 mg Brexpiprazole, and 4 mg Brexpiprazole. The y-axis represents change from baseline with negative values, and the x-axis represents weeks from 0 to 6. Lines indicate that both 2 mg and 4 mg Brexpiprazole groups show greater negative change from baseline compared to placebo over time.*

FDA Label Image

Figure6 (Brexpiprazole Figure6)

A Kaplan-Meier curve chart showing the percentage of subjects with impending relapse over days from randomization for brexpiprazole (BREX) versus placebo. The y-axis indicates relapse percentage, and the x-axis shows days up to 378. BREX group curve is lower than placebo, indicating fewer relapses. Numbers of subjects at risk are noted below the x-axis for both groups.*

FDA Label Image

Structure (Brexpiprazole Structure)

Chemical structure of brexpiprazole, showing the molecular framework including a thienobenzodiazepine core linked to a piperazine ring and a quinolinone moiety with various functional groups.*

* 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.