Asenapine Tablet
Product Images NDC 46708-199

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Asenapine (NDC 46708-199). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic Pharmaceuticals 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

Asenapine-structure (Asenapine Structure)

Chemical structure of asenapine, depicting its molecular composition including a chlorine atom, aromatic rings, and a methyl group attached to a nitrogen, alongside an acetic acid component.*

FDA Label Image

Asenapine-figure1 (Asenapine Figure1)

A fold change chart depicting the effect of various CYP inhibitors on Asenapine pharmacokinetics. The chart compares the fold change in maximum concentration (Cmax) and area under curve (AUC) with 90% confidence intervals for inhibitors like Fluvoxamine, Imipramine, Paroxetine, Cimetidine, Carbamazepine, and Valproate relative to reference values.*

FDA Label Image

Figure 2 (Asenapine 2 Figure)

A forest plot illustrating the fold change and 90% confidence intervals in pharmacokinetic parameters (Cmax and AUC) of various CYP substrates/inhibitors (Paroxetine, Imipramine, Desipramine) relative to reference values. The chart highlights the interaction of Asenapine with these CYP enzymes, showing fold changes above or near 1.*

FDA Label Image

Figure 3 (Asenapine Fig3)

A forest plot chart illustrating fold changes and 90% confidence intervals of pharmacokinetic parameters Cmax and AUC across various populations, including renal and hepatic impairment (mild to severe), smokers, Japanese, and pediatrics. The x-axis denotes change relative to reference, with most populations clustered near 1 except severe hepatic impairment showing a higher fold change.*

FDA Label Image

Figure 4 (Asenapine Fig 4)

A line graph depicting the percentage of relapse or impending relapse status over time (days) comparing Asenapine and placebo groups. The graph shows data points for days up to 210, with percent on the y-axis and time in days on the x-axis. Two lines represent Asenapine (solid) and placebo (dotted), with placebo showing higher relapse percentages over time. A table below lists the number of subjects at risk at various time points for both groups.*

FDA Label Image

Figure 5 (Asenapine Figure 5)

A Kaplan-Meier survival curve comparing the percentage of patients achieving relapse status over time (days) between Asenapine and Placebo groups. The x-axis represents time in days from randomization, and the y-axis shows the percent reaching relapse. The chart includes a table showing the number of patients at risk over time for each treatment group.*

FDA Label Image

Figure A (Asenapine Figure A)

An instructional illustration showing a hand holding and detaching a single blister pack segment from a larger, perforated blister card, indicating how to separate individual doses for use or dispensing.*

FDA Label Image

Figure B (Asenapine Figure B)

An instructional illustration showing hands peeling back a flap on a single-dose blister pack, revealing a round sublingual tablet inside, indicating how to open the packaging for use.*

FDA Label Image

Figure C (Asenapine Figure C)

An instructional illustration showing a hand holding a single tablet in a blister pack, with an arrow indicating to peel back the foil to access the tablet. This depicts how to remove a sublingual Asenapine tablet from its packaging.*

FDA Label Image

Asenapine-figured (Asenapine Figured)

An instructional illustration showing a person holding a sublingual tablet with their fingers near the mouth, about to place it under the tongue. The image emphasizes the sublingual route of administration for the Asenapine tablet.*

FDA Label Image

Asenapine-figuree (Asenapine Figuree)

Instructional illustration showing a crossed-out image of eating utensils and a glass of water, with a label indicating '10 minutes.' This likely advises against eating or drinking for 10 minutes after medication administration.*

FDA Label Image

60 Tablets (Asenapine 2 5)

Asenapine Sublingual Tablets 2.5 mg per tablet packaging label from Alembic Pharmaceuticals Limited. The label indicates a child-resistant package containing 60 tablets (6 x 10 unit-dose). It includes usage instructions emphasizing sublingual administration only, warnings not to split, cut, or crush the tablet, and handling directions. The label also lists storage conditions, inactive ingredients, and presents step-by-step illustrated instructions for removing and administering the tablet.*

FDA Label Image

60 Tablets (Asenapine 5)

Packaging label for Asenapine Sublingual Tablets 10 mg by Alembic Pharmaceuticals Limited. The label shows the product name, strength, dosage form, and quantity (60 tablets, 6 x 10 unit-dose). It includes instructions for sublingual use only, warnings not to chew or swallow the tablet, and directions on how to open the child-resistant package. The label also lists storage conditions and inactive ingredients and features a barcode.*

FDA Label Image

60 Tablets (Asenapine 10 mg)

Asenapine Sublingual Tablets 10 mg box packaging label by Alembic Pharmaceuticals Limited. The label includes dosage form as sublingual tablets with warnings not to split, cut, crush, chew, or swallow the tablet. Instructions with illustrations show proper removal of tablets from blister packs and correct sublingual placement. Storage information and detailed ingredients list are also present along with bar code and NDC 46708-199-60.*

* 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.