Chemical Structure (Secuado 01)
Chemical structure of asenapine, showing its fused ring system with a chlorine atom and nitrogen-containing heterocycle.*
Secuado Film, Extended Release
Product Images NDC 68968-0173
22 FDA label images from Noven Therapeutics, Llc · Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Secuado (NDC 68968-0173). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Noven Therapeutics, 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.
Product Images & Figures Index
Fig1 (Secuado 02)
A fold change and 90% confidence interval chart showing pharmacokinetic parameters Cmax and AUC for SECUADO (as indicated by product data) across different populations: mild, moderate, and severe renal impairment; mild, moderate, and severe hepatic impairment; smokers; and Japanese subjects. The chart compares these values relative to reference groups, indicating how these conditions affect drug exposure.*
Fig2 (Secuado 03)
A fold change and 90% confidence interval chart displaying the effects of various CYP inhibitors and an inducer on the pharmacokinetics (Cmax and AUC) of asenapine. The graph shows changes relative to a reference value of 1.0, indicating various increases or decreases in asenapine exposure with agents including fluvoxamine, imipramine, paroxetine, cimetidine, carbamazepine, and valproate.*
Fig3 (Secuado 04)
A pharmacokinetic chart showing fold change and 90% confidence intervals for Cmax and AUC values of CYP2D6 substrates/inhibitors paroxetine, imipramine, and desipramine relative to a reference. The chart includes notes describing asenapine's potential inhibitory effects on CYP2D6 activity in vivo and effects observed in clinical studies with various doses.*
Fig4 (Secuado 05)
A line graph showing least squares mean change from baseline over a six-week study period comparing SECUADO 7.6 mg/24 hours, SECUADO 3.8 mg/24 hours, and placebo. The y-axis measures change from baseline, while the x-axis represents study visits by week. The graph includes patient counts remaining at each time point for all three groups.*
Fig5 (Secuado 06)
A Kaplan-Meier plot showing the percentage of patients who achieved relapse or impending relapse status over time (days) for sublingual asenapine versus placebo. The solid line represents sublingual asenapine, and the dashed line represents placebo. The chart includes a table of patients at risk over time for each group.*
Step 1 (Secuado 07)
An instructional illustration showing four possible skin locations for applying a transdermal film drug: upper arm, upper back, abdomen, and hip, each depicted with a square indicating the patch area on a grey silhouette of a human torso.*
Step 2 (Secuado 08)
Illustration showing hands cutting open a sealed pouch with scissors on the left, and then peeling back the backing from a transdermal film on the right, demonstrating how to remove the SECUADO (asenapine) extended release film from its packaging.*
Step 3 (Secuado 09)
Instructional illustration showing how to peel apart the backing of a SECUADO transdermal film patch. It depicts hands separating the protective layers to prepare the extended-release film for application.*
Step 4 (Secuado 10)
An instructional illustration showing the application of a SECUADO (asenapine) extended-release transdermal film patch on the skin of the upper arm. A magnified inset highlights proper placement and adhesion of the patch to the skin.*
Step 5 (Secuado 11)
Illustration showing the application of SECUADO transdermal film on the upper arm. The first frame depicts a hand peeling the backing off the film, and the second frame shows the film being pressed firmly onto the skin.*
Step 6 (Secuado 12)
Illustration showing a person applying a transdermal film to the upper arm, demonstrating the proper placement for SECUADO (asenapine) extended-release transdermal film.*
Step 7 (Secuado 13)
Illustration showing a person washing their hands under a running faucet with soap dispenser in the background. The image depicts hand hygiene technique, likely related to proper care instructions for a transdermal film product.*
Step 8 (Secuado 14)
An instructional illustration showing how to fold the SECUADO film-shaped transdermal patch before use, indicated by a curved arrow pointing from a flat open patch to a folded one.*
Step 9 (Secuado 15)
An instructional illustration showing a hand disposing of a small rectangular film into a lined trash can. This likely demonstrates proper disposal of a film dosage form, such as the SECUADO transdermal extended release film.*
Step 10 (Secuado 16)
Illustration showing a pair of hands being washed with soap under a running faucet, likely demonstrating hygiene before or after applying a transdermal film like SECUADO (asenapine). A soap dispenser is visible next to the faucet.*
Carton Label (3.8 mg)
The packaging label for SECUADO (asenapine) transdermal system, 3.8 mg/24 hours. The box contains 30 extended-release transdermal film systems for transdermal use only, labeled by Noven Therapeutics, LLC. The label includes dosing strength, usage instructions, inactive ingredients, storage conditions, and a QR code.*
Carton Label (5.7 mg)
Packaging label for SECUADO (asenapine) transdermal system, 5.7 mg/24 hours. The label shows it is for human prescription use, with 30 extended release transdermal film systems per package. The label lists Noven Therapeutics, LLC as the manufacturer and provides dosing instructions and inactive ingredient information.*
Carton Label (7.6 mg)
Packaging label for Secuado (asenapine) transdermal system 7.6 mg/24 hours by Noven Therapeutics, LLC. The carton indicates 30 transdermal systems for prescription use only. The label lists inactive ingredients and instructions to use one system at a time, with storage advice at 20°C to 25°C. The labeler is Noven Therapeutics, LLC, distributed by Noven Pharmaceutical Co., Inc.*
Pouch Label (3.8 mg)
Label for SECUADO (asenapine) transdermal system 3.8 mg/24 hours, an extended-release transdermal film. Front label includes dosage strength, prescription-only status, and usage instructions. Manufactured by Hisamitsu Pharmaceutical Co., Inc. and distributed by Noven Therapeutics, LLC. Contains inactive ingredients and storage instructions.*
Pouch Label (5.7 mg)
Packaging label for SECUADO (asenapine) transdermal system, 5.7 mg/24 hours. This film extended-release transdermal system is for human prescription use, manufactured by Hisamitsu Pharmaceutical Co., Inc. and distributed by Noven Therapeutics, LLC. The label includes dosage strength, instructions for transdermal use, inactive ingredients, storage conditions, lot number, and expiration date placeholders.*
Pouch Label (7.6 mg)
SECUADO 7.6 mg/24 hours transdermal system film label showing it contains asenapine for transdermal use. Includes inactive ingredients, usage instructions, and storage conditions. Manufactured by Hisamitsu Pharmaceutical Co., Inc. and distributed by Noven Therapeutics, LLC. Barcode, lot number AB123, and expiration date placeholder also visible.*
* 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.
