Asenapine Tablet
Product Images NDC 62332-199

17 FDA label images from Alembic Pharmaceuticals Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Asenapine (NDC 62332-199). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic Pharmaceuticals 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

Asenapine-structure (Asenapine Structure)

Asenapine-structure (Asenapine Structure)
Chemical structure diagram showing the molecular structure of Asenapine and an associated acetic acid molecule, illustrating the active ingredient's chemical composition in the product. The structure includes chlorine, oxygen, nitrogen, and carbon atoms arranged in rings and chains.*
FDA Label Image

Asenapine-figure1 (Asenapine Figure1)

Asenapine-figure1 (Asenapine Figure1)
A forest plot chart showing fold change and 90% confidence intervals in pharmacokinetic parameters (Cmax and AUC) of asenapine when co-administered with various CYP inhibitors, including Fluvoxamine, Imipramine, Paroxetine, Cimetidine, Carbamazepine, and Valproate. The horizontal axis shows change relative to reference from 0.5 to 2, with most values near 1.0.*
FDA Label Image

Figure 2 (Asenapine 2 Figure)

Figure 2 (Asenapine 2 Figure)
A chart depicting fold change and 90% confidence intervals showing the pharmacokinetic effects of Asenapine on CYP2D6, CYP1A2/2C19/3A4, and CYP2C19/2D6 substrates. The graph compares changes in Cmax and AUC relative to reference for drugs including Paroxetine, Imipramine, and Desipramine.*
FDA Label Image

Figure 3 (Asenapine Fig3)

Figure 3 (Asenapine Fig3)
A forest plot showing fold changes with 90% confidence intervals in pharmacokinetic parameters (Cmax and AUC) of Asenapine for various population subgroups, including mild, moderate, and severe renal and hepatic impairment, smokers, Japanese patients, and pediatrics. The plot compares these groups to reference populations.*
FDA Label Image

Figure 4 (Asenapine Fig 4)

Figure 4 (Asenapine Fig 4)
A line graph comparing the percentage of relapse/impend relapse status over time in days between Asenapine and placebo groups. The x-axis shows time in days up to 225, and the y-axis shows percent relapse up to 100%. The graph includes count data of subjects at risk for each time point for both groups.*
FDA Label Image

Figure 5 (Asenapine Figure 5)

Figure 5 (Asenapine Figure 5)
A Kaplan-Meier curve graph comparing Asenapine versus placebo over time (in days) showing the percent of subjects achieving relapse status. The solid line represents Asenapine, and the dashed line represents placebo, with a table below showing the number of subjects at risk at various time points during the study.*
FDA Label Image

Figure A (Asenapine Figure A)

Figure A (Asenapine Figure A)
Illustration showing a hand holding a single blister strip of Asenapine sublingual tablets, pulling it away from a larger connected set. The image depicts the separation of individual blister packs for dispensing or use.*
FDA Label Image

Figure B (Asenapine Figure B)

Figure B (Asenapine Figure B)
Illustration showing a person peeling back the foil cover of a blister pack to access a sublingual tablet. The image demonstrates how to open the individual tablet packaging by lifting the pointed tab.*
FDA Label Image

Figure C (Asenapine Figure C)

Figure C (Asenapine Figure C)
An instructional illustration showing hands peeling back a foil blister to remove a single sublingual tablet. A black arrow points downward indicating the direction to peel the foil, demonstrating how to access the Asenapine sublingual tablet.*
FDA Label Image

Asenapine-figured (Asenapine Figured)

Asenapine-figured (Asenapine Figured)
An illustration showing a person placing a sublingual tablet under the tongue using their hand, demonstrating the correct method for sublingual administration.*
FDA Label Image

Asenapine-figuree (Asenapine Figuree)

Asenapine-figuree (Asenapine Figuree)
An instructional illustration showing a crossed-out fork and knife beside a glass of water and a box labeled "10 minutes," indicating no food or drink intake for 10 minutes, likely related to sublingual tablet administration.*
FDA Label Image

10 Tablets (Asenapine 2 5 Monocarton)

10 Tablets (Asenapine 2 5 Monocarton)
Asenapine Sublingual Tablets 2.5 mg carton label from Alembic Pharmaceuticals Inc. This human prescription drug is presented in a 10-tablet blister pack. The label includes instructions emphasizing sublingual use, warnings against chewing or swallowing, and careful blister handling. Manufacturer details for Alembic Pharmaceuticals Limited, India, and Alembic Pharmaceuticals, Inc., USA, are provided along with storage conditions and ingredient information.*
FDA Label Image

60 Tablets (Asenapine 2 5 mg Outercarton)

60 Tablets (Asenapine 2 5 mg Outercarton)
Asenapine Sublingual Tablets 2.5 mg per tablet packaging label by Alembic Pharmaceuticals Inc. The label includes instructions for sublingual use only, warnings against splitting or chewing the tablet, and detailed steps with illustrations for removing the tablet from the blister pack and placing it under the tongue. The package contains 60 tablets (6 x 10 unit-dose blister packs) and lists inactive ingredients and storage conditions.*
FDA Label Image

10 Tablets (Asenapine 5 Monocarton)

10 Tablets (Asenapine 5 Monocarton)
Packaging label for Asenapine Sublingual Tablets, 5 mg strength, sublingual tablet dosage form. The carton contains 10 tablets and is labeled by Alembic Pharmaceuticals Inc. The label includes instructions emphasizing sublingual use only, warnings against splitting, chewing, swallowing, and directions for use. Manufacturer details and storage instructions are also present.*
FDA Label Image

60 Tablets (Asenapine 5 Outercarton)

60 Tablets (Asenapine 5 Outercarton)
Packaging label for Asenapine Sublingual Tablets 5 mg by Alembic Pharmaceuticals Inc. The label includes dosage form as sublingual tablets with a quantity of 60 tablets (6 x 10 Unit-Dose). Usage instructions warn to use sublingually under the tongue, not to split, chew, swallow, or push tablets through the pack. It also features step-by-step illustrations for tablet removal and administration, plus storage conditions and ingredient information.*
FDA Label Image

10 Tablets (Asenapine 10 Monocarton)

10 Tablets (Asenapine 10 Monocarton)
Packaging label for Asenapine Sublingual Tablets, 10 mg per tablet, containing 10 tablets. The label indicates the tablets are for sublingual use only and must not be split, cut, crushed, chewed, or swallowed. It is manufactured by Alembic Pharmaceuticals Limited and labeled for Alembic Pharmaceuticals Inc. The label includes usage instructions with illustrated steps for opening the blister and proper administration.*
FDA Label Image

60 Tablets (Asenapine 10 Outercarton)

60 Tablets (Asenapine 10 Outercarton)
Asenapine Sublingual Tablets 10 mg per tablet carton label for 60 tablets (6 x 10 Unit-Dose) by Alembic Pharmaceuticals Inc. The label displays dosage form as sublingual tablets, manufacturer information, and detailed instructions for tablet removal and use. It includes warnings against splitting, chewing, or swallowing the tablet and storage conditions at controlled room temperature.*

* 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.