Asenapine Tablet
Product Images NDC 69539-057

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Asenapine (NDC 69539-057). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Msn Laboratories Private Limited, 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

10mg-flavor (10mg Flavor)

Asenapine Sublingual Tablets 10 mg Black Cherry Flavor packaging label. The label indicates sublingual administration, packaging of 60 unit-dose tablets (6x10), and includes warnings about usage and phenylketonurics. Manufactured by MSN Laboratories Private Limited and distributed by Breckenridge Pharmaceutical, Inc. The label contains dosage form, strength, flavor, and storage instructions along with use directions and barcode.*

FDA Label Image

10mg Unflav Carton

Asenapine Sublingual Tablets 10 mg packaging label showing the product name, strength, and form. The label includes dosage form instructions, phenylalanine warning, and manufacturer information for MSN Laboratories Private Limited. It also displays the package count of 60 unit-dose tablets and Breckenridge Pharmaceutical as distributor. The label features handling and usage instructions with illustrations.*

FDA Label Image

2 5mg Flavor Carton

Asenapine Sublingual Tablets 2.5 mg black cherry flavor in a unit-dose package containing 60 tablets (6x10). The label specifies sublingual use only with warnings against splitting, cutting, chewing, or swallowing tablets. Manufactured by MSN Laboratories Private Limited and distributed by Breckenridge Pharmaceutical, Inc. The packaging includes dosage, storage instructions, and illustrated tablet use directions.*

FDA Label Image

5mg Flavor Carton

Asenapine Sublingual Tablets 5 mg in black cherry flavor, packaged by MSN Laboratories Private Limited. This label indicates the sublingual tablet form with each tablet containing 5 mg asenapine maleate. The package includes 60 tablets in unit-dose blisters and is distributed by Breckenridge Pharmaceutical, Inc. Usage instructions and storage information are also provided.*

FDA Label Image

5mg Unflav Carton

Asenapine Sublingual Tablets 5 mg packaging label for sublingual use only. The label includes the product name, strength, route (sublingual under the tongue), and quantity (60 tablets in unit-dose packaging). It contains warnings about phenylketonurics, instructions not to split or chew the tablet, and directions for use with illustrations. The manufacturer is MSN Laboratories Private Limited, and the distributor is Breckenridge Pharmaceutical, Inc.*

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Structure (Asenapine 01)

Chemical structure of asenapine maleate, showing the molecular arrangement including a chlorinated aromatic ring, a nitrogen-containing bicyclic system with a methyl group, and maleate moiety represented by two carboxyl groups.*

FDA Label Image

Figure-1 (Asenapine 02)

A fold change chart displaying the effect of various enzyme inhibitors and inducers on the pharmacokinetics (Cmax and AUC) of Asenapine. The graph plots fold change and 90% confidence intervals relative to reference for inhibitors such as Fluvoxamine, Imipramine, Paroxetine, Cimetidine, Carbamazepine, and Valproate.*

FDA Label Image

Figure-2 (Asenapine 03)

A pharmacokinetic (PK) fold change graph illustrating the effect of different CYP enzyme substrates/inhibitors on the Cmax and AUC of Asenapine maleate. It compares the relative change and 90% confidence intervals for Paroxetine (CYP2D6 inhibitor), Imipramine (CYP1A2/2C19/3A4 substrate), and Desipramine (CYP2C19/2D6 substrate) against a reference value on a horizontal scale from 0.5 to 2.5.*

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Figure-3 (Asenapine 04)

A forest plot chart showing fold change and 90% confidence intervals of pharmacokinetic parameters Cmax and AUC for different populations relative to reference groups. Populations include mild, moderate, and severe renal impairment; mild, moderate, and severe hepatic impairment; smokers; Japanese subjects; and pediatrics. The x-axis represents change relative to reference values from 0 to 10.*

FDA Label Image

Figure-4 (Asenapine 05)

A Kaplan-Meier curve comparing the percentage of patients experiencing relapse or impending relapse over time (days) between Asenapine sublingual tablets and placebo. The solid line represents Asenapine sublingual tablets, showing a lower percentage than the dashed line representing placebo across the study duration. The graph includes patient numbers at risk at various time points below the x-axis.*

FDA Label Image

Figure-5 (Asenapine 06)

A Kaplan-Meier survival curve comparing relapse status over time in days between Asenapine sublingual tablets and placebo groups. The y-axis shows the percent relapse, and the x-axis shows time in days up to 240 days. Data tables below the graph indicate the number of subjects at risk over time in both groups.*

FDA Label Image

Step-1 (Asenapine 07)

Instructional illustration showing hands removing a single tablet from a blister pack, indicated by an arrow guiding the blister peel direction. The image depicts proper tablet extraction from individual sealed compartments.*

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Step-2 (Asenapine 08)

An instructional illustration depicting a hand placing a sublingual tablet under the tongue, demonstrating the proper route of administration for the Asenapine sublingual tablet.*

FDA Label Image

Step-3 (Asenapine 09)

An instructional diagram illustrating hands holding a tablet blister pack, with an arrow pointing to a single tablet, demonstrating how to press and push out the tablet from the blister.*

FDA Label Image

Step-4 (Asenapine 10)

Illustration demonstrating the sublingual administration of an Asenapine tablet by placing it under the tongue. The image shows a hand positioning a tablet beneath the tongue of an open mouth.*

FDA Label Image

Figure-e (Asenapine 11)

Illustration showing a glass of water and a crossed-out fork, knife, and spoon symbol next to a label reading '10 minutes,' indicating a restriction on eating or drinking for 10 minutes.*

* 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.