Rexulti Tablet
Product Images NDC 59148-039

19 FDA label images from Otsuka America Pharmaceutical, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Rexulti (NDC 59148-039). 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

Rexulti 025mg Bottle Label

Rexulti 025mg Bottle Label
Rexulti 0.25 mg tablets packaging label showing a box with 30 tablets of brexpiprazole oral tablets. The label includes the NDC 59148-035-13, manufacturer information (Otsuka Pharmaceutical), and instructions to dispense the medication guide with each patient. The label prominently displays the proprietary name Rexulti and generic name brexpiprazole with strength 0.25 mg.*
FDA Label Image

Rexulti 025mg Carton

Rexulti 025mg Carton
Carton packaging label for Rexulti brexpiprazole tablets, 0.25 mg strength, containing 30 tablets. The label features the Rexulti logo with a green and gold ribbon design, and indicates the product is prescription only. The labeler is Otsuka America Pharmaceutical, Inc., with storage instructions and barcode on one panel.*
FDA Label Image

Rexulti 05mg Bottle Label

Rexulti 05mg Bottle Label
Rexulti 0.5 mg brexpiprazole tablets packaging label showing a 30-tablet count. The label includes the NDC number 59148-036-13, manufacturer Otsuka Pharmaceutical Co., and distributor Otsuka America Pharmaceutical, Inc. The label cautions to keep out of reach of children and to dispense the accompanying medication guide to each patient.*
FDA Label Image

Rexulti 05mg Carton

Rexulti 05mg Carton
Packaging label for Rexulti brexpiprazole tablets 0.5 mg, oral tablet form. The label includes a 30-tablet count, NDC 59148-036-13, with warnings to keep out of reach of children and to dispense the accompanying medication guide. Manufactured by Otsuka America Pharmaceutical, Inc., the label features the Rexulti logo and dosage strength prominently on a white background with orange, green, and yellow accents.*
FDA Label Image

Rexulti 1mg Bottle Label

Rexulti 1mg Bottle Label
Rexulti 1 mg tablets packaging label showing 30 tablets. The label displays the proprietary name Rexulti and the generic name brexpiprazole. It includes the NDC number 59148-037-13 and states Rx only. The label also notes the manufacturer as Otsuka Pharmaceutical Co., with distribution by Otsuka America Pharmaceutical, Inc. and marketing by Lundbeck. Storage information is partially visible along the right side.*
FDA Label Image

Rexulti 1mg Carton

Rexulti 1mg Carton
Rexulti 1 mg brexpiprazole tablets carton label for 30 tablets. The label features the Rexulti logo, strength "1 mg," and states Rx only. It includes storage instructions and manufacturer details for Otsuka America Pharmaceutical, Inc. The design uses yellow and green triangular sections with a barcode and lot information area visible.*
FDA Label Image

Rexulti 2mg Bottle Label

Rexulti 2mg Bottle Label
The image shows a blister pack label for Rexulti 2 mg tablets containing brexpiprazole. The label indicates a quantity of 30 tablets, with the NDC number 59148-038-13. The packaging includes manufacturer and distributor information, usage instructions to keep out of children's reach, and a note to dispense the accompanying medication guide. It is labeled for prescription use only, marketed by Otsuka America Pharmaceutical, Inc.*
FDA Label Image

Rexulti 2mg Carton

Rexulti 2mg Carton
Packaging label for Rexulti 2 mg tablets containing brexpiprazole. The label indicates a count of 30 tablets per package and features the Otsuka logo. The design includes safety instructions, storage information, barcode, and the Rx only designation. The labeler is Otsuka America Pharmaceutical, Inc.*
FDA Label Image

Rexulti 3mg Bottle Label

Rexulti 3mg Bottle Label
Rexulti 3 mg tablets packaging label showing the brand name and generic name brexpiprazole. The label indicates a count of 30 tablets, the NDC number 59148-039-13, and that the product is by Otsuka America Pharmaceutical, Inc. It includes storage and dispensing information and cautions to keep out of reach of children.*
FDA Label Image

Rexulti 3mg Carton

Rexulti 3mg Carton
Rexulti 3 mg brexpiprazole tablets carton label for 30 tablets. The label shows the brand name Rexulti with the generic name brexpiprazole tablets, strength 3 mg, and a yellow warning box labeled 'Rx only' and 'Keep out of the reach of children.' Manufacturer is Otsuka America Pharmaceutical, Inc. The barcode and storage instructions are visible, along with marketing information for Lundbeck.*
FDA Label Image

Rexulti 4mg Bottle Label

Rexulti 4mg Bottle Label
Rexulti 4 mg tablets carton label showing 30 tablets. The label states the active ingredient brexpiprazole and includes directions to dispense the medication guide to each patient. It displays the NDC 59148-040-13 and notes that it is Rx only. Manufactured by Otsuka Pharmaceutical Co. and distributed by Otsuka America Pharmaceutical, Inc. The label features storage instructions and regulatory information.*
FDA Label Image

Rexulti 4mg Carton

Rexulti 4mg Carton
Packaging label for Rexulti 4 mg brexpiprazole tablets, containing 30 tablets per container. The label displays the brand name Rexulti and generic name brexpiprazole, with a strength of 4 mg per tablet. It indicates prescription use only, with warnings to keep out of the reach of children and to dispense the accompanying medication guide. Labeler is Otsuka America Pharmaceutical, Inc., with manufacturing information from Otsuka Pharmaceutical Co., Ltd.*
FDA Label Image

Rexulti Chem Structure

Rexulti Chem Structure
Chemical structure of brexpiprazole, the active ingredient in Rexulti tablets. The diagram displays the molecular arrangement including rings and functional groups characteristic of brexpiprazole.*
FDA Label Image

Rexulti Figure 01

Rexulti Figure 01
A chart illustrating the fold change and 90% confidence intervals in brexpiprazole pharmacokinetic measures (Cmax and AUCinf) relative to reference values. The graph compares these measures across different conditions including severe renal impairment, mild to severe hepatic impairment, and population descriptions by gender and age groups, including comparisons between adults and elderly, males and females.*
FDA Label Image

Rexulti Figure 02

Rexulti Figure 02
A scatter plot chart showing fold change and 90% confidence intervals for brexpiprazole pharmacokinetic measures (Cmax and AUCinf) affected by various inhibitors and an inducer. It compares changes relative to reference without interacting drugs for CYP3A4 inhibitor (ketoconazole), CYP2D6 inhibitor (quinidine), CYP3A4 inducer (rifampin), CYP2B6 inhibitor (ticlopidine), and gastric pH increase (omeprazole).*
FDA Label Image

Rexulti Figure 03

Rexulti Figure 03
A forest plot showing the fold change and 90% confidence intervals for pharmacokinetic measures of various analytes affected by Rexulti (brexpiprazole). It includes CYP2D6 substrate dextromethorphan urine DM X/DX ratio, P-gp substrate fexofenadine Cmax and AUCinf, CYP2B6 substrate bupropion Cmax and AUCinf for bupropion and hydroxy bupropion, CYP3A4 substrate lovastatin Cmax and AUCt and hydroxyl acid Cmax and AUCt, and BCRP substrate rosuvastatin Cmax and AUCinf. The x-axis represents change relative to reference without interacting drug.*
FDA Label Image

Rexulti Figure 04

Rexulti Figure 04
A line graph showing change from baseline over six weeks comparing ADT plus placebo versus ADT plus brexpiprazole 2 mg. The vertical axis indicates change from baseline, and the horizontal axis shows weeks. Two lines represent the groups, with the brexpiprazole 2 mg group showing a greater decrease over time.*
FDA Label Image

Rexulti Figure 05

Rexulti Figure 05
Line graph showing change from baseline over six weeks comparing placebo, 2 mg brexpiprazole, and 4 mg brexpiprazole groups. The y-axis represents change from baseline, and the x-axis represents weeks from 0 to 6. Data points show a greater decrease from baseline for both brexpiprazole doses versus placebo throughout the study period.*
FDA Label Image

Rexulti Figure 06

Rexulti Figure 06
A Kaplan-Meier curve chart showing the percentage of subjects with impending relapse over time in days from randomization, comparing two groups: one receiving Placebo and the other receiving BREX (brexpiprazole). The chart displays lower relapse rates for BREX compared to Placebo throughout the study period, with numbers of subjects at risk indicated below the x-axis for both 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.