Asenapine Tablet
Product Images NDC 42794-016

12 FDA label images from Sigmapharm Laboratories, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Asenapine (NDC 42794-016). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sigmapharm Laboratories, Llc, 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

Asp-1 (Asp 1)

Asp-1 (Asp 1)
Chemical structure diagram of asenapine, showing its molecular configuration including a chlorine-substituted bicyclic system and a methylated nitrogen, paired with an acid component likely representing a salt form.*
FDA Label Image

Asp-10 (Asp 10)

Asp-10 (Asp 10)
Asenapine Sublingual Tablets 10 mg label for a 60-tablet bottle by Sigmapharm Laboratories, LLC. It includes directions to not split, cut, crush, chew, or swallow the tablet. The label specifies storage conditions, sublingual use instructions with a graphic, and that the tablets have a black cherry flavor.*
FDA Label Image

Asp-12 (Asp 12)

Asp-12 (Asp 12)
Asenapine Sublingual Tablets 5 mg label from Sigmapharm Laboratories, LLC, showing a 10-count bottle for sublingual use. The label cautions not to split, cut, crush, chew, or swallow tablets and instructs to place the whole tablet under the tongue to dissolve. Storage instructions and usage warnings are also included.*
FDA Label Image

Asp-13 (Asp 13)

Asp-13 (Asp 13)
Asenapine Sublingual Tablets 5 mg in a 30-tablet bottle package label from Sigmapharm Laboratories, LLC. The label notes black cherry flavor, storage instructions between 20°-25°C (68°-77°F), and directions emphasizing sublingual use only, not to split, chew, or swallow tablets, and to place the whole tablet under the tongue allowing it to dissolve completely before eating or drinking for 10 minutes.*
FDA Label Image

Asp-14 (Asp 14)

Asp-14 (Asp 14)
Asenapine Sublingual Tablets 10 mg label by Sigmapharm Laboratories, LLC. The label cautions not to split, cut, crush, chew, or swallow the tablet and to dispense only in the original container. It contains 10 tablets with black cherry flavor. Directions emphasize sublingual use only, placing the whole tablet under the tongue to dissolve completely, and avoiding eating or drinking for 10 minutes after use. Storage instructions and barcode are also included.*
FDA Label Image

Asp-15 (Asp 15)

Asp-15 (Asp 15)
Asenapine Sublingual Tablets 10 mg label from Sigmapharm Laboratories, LLC, Bensalem, PA. The label states not to split, cut, crush, chew, or swallow the tablet, and it is to be dispensed only in the original container. The package contains 30 black cherry flavored tablets. Storage instructions include maintaining temperature between 20°-25°C with permitted excursions, and usage instructions emphasize sublingual use and not eating or drinking for 10 minutes after administration.*
FDA Label Image

Asp-2 (Asp 2)

Asp-2 (Asp 2)
A forest plot chart showing fold changes and 90% confidence intervals in pharmacokinetics parameters Cmax and AUC of Asenapine when co-administered with various enzyme inhibitors and inducers. The chart lists CYP1A2 inhibitor Fluvoxamine, CYP1A2/2C19/3A4 inhibitor Imipramine, CYP2D6 inhibitor Paroxetine, CYP3A4/2D6/1A2 inhibitor Cimetidine, CYP3A4 inducer Carbamazepine, and UGT1A4 inhibitor Valproate with their respective fold change values relative to reference on a scale from 0.5 to 2.0.*
FDA Label Image

Asp-3 (Asp 3)

Asp-3 (Asp 3)
A chart showing fold change and 90% confidence intervals (CI) of pharmacokinetic parameters (Cmax and AUC) for drugs metabolized by CYP2D6, CYP1A2/2C19/3A4, and CYP2C19/2D6 enzymes. The drugs include Paroxetine, Imipramine, and Desipramine, with fold change values plotted against a reference line at 1.0 on the x-axis, ranging from 0.5 to 2.5.*
FDA Label Image

Asp-4 (Asp 4)

Asp-4 (Asp 4)
A forest plot graph showing fold changes and 90% confidence intervals (CI) for maximum concentration (Cmax) and area under the curve (AUC) in various populations such as renal impaired (mild, moderate, severe), hepatic impaired (mild, moderate, severe), smokers, and Japanese subjects. The x-axis represents change relative to reference with values ranging from 0 to 10.*
FDA Label Image

Asp-6 (Asp 6)

Asp-6 (Asp 6)
An illustration showing a person placing an Asenapine sublingual tablet under their tongue, demonstrating the correct method for sublingual administration.*
FDA Label Image

Asp-7 (Asp 7)

Asp-7 (Asp 7)
An instructional illustration showing a crossed-out glass and utensils (fork and knife) inside a circle above the text '10 minutes.' This indicates not to eat or drink for 10 minutes.*
FDA Label Image

Asp-8 (Asp 8)

Asp-8 (Asp 8)
Asenapine Sublingual Tablets 5 mg label showing dosage form as sublingual tablets with a black cherry flavor. The label includes warnings not to split, cut, crush, chew, or swallow the tablet and states that the package contains 60 tablets. Labeler information is Sigmapharm Laboratories, LLC, Bensalem, PA. Directions emphasize placing the whole tablet under the tongue to dissolve and not eating or drinking for 10 minutes after use.*

* 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.