Chemical Structure (Asenapine 01)
Asenapine Tablet
Product Images NDC 51991-359
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Asenapine (NDC 51991-359). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Breckenridge Pharmaceutical, 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.
Product Images & Figures Index
Figure 1 (Asenapine 02)
This text appears to be a table listing different drugs and their effects on the metabolic enzymes in the body. It includes information on which drugs inhibit or induce certain enzymes and their impact on pharmacokinetic parameters such as Cmax and AUC. Additionally, there is an example given of the effect of the CYP1A2 inhibitor fluvoxamine on asenapine exposure. Overall, this table could be useful for clinicians in understanding potential drug interactions and their effects on medication metabolism.*
Figure 2 (Asenapine 03)
Figure 3 (Asenapine 04)
This text provides information on population description based on Renal and Hepatic impairment, smoker, Japanese ethnicity, and Pediatries. The data includes information on PK, Cmax, AUC, and fold change with 90% CI. The reference population for renal and hepatic impairment is individuals with normal renal and hepatic function, respectively. Furthermore, the data for smokers is relative to non-smokers, whereas the data for Japanese is relative to Caucasians, and the data for pediatrics is relative to adults.*
Figure 4 (Asenapine 05)
Figure 5 (Asenapine 06)
The text describes a graph comparing the efficacy of Asenapine sublingual tablets versus placebo, represented by the number of days to relapse. The graph shows that Asenapine resulted in a longer time to relapse than placebo. The estimators used in the graph are based on the Kaplan-Meier distribution with censoring.*
Figure A (Asenapine 07)
Figure B (Asenapine 08)
Figure C (Asenapine 09)
Figure D (Asenapine 10)
Figure E (Asenapine 11)
Principal Display Panel (10 mg Tablet Blister Pack Box)
Asenapine sublingual tablets are available in a pack containing 60 unit-dose sublingual tablets. Each sublingual tablet contains asenapine (5mg as maleate), aspartame, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and peppermint flavor. This medication should be used only by placing the tablet under the tongue. The pack must be stored at 20° to 25° C (66° to 77° F). It is manufactured and distributed by Torga Pharmaceuticals. It is important to keep the medication out of the reach of children. This medicine may contain Phenylalanine in the amount of 0.17 mg per tablet.*
Principal Display Panel (2.5 mg Tablet Blister Pack Box)
The text is a product description for Asenapine Sublingual Tablets with the warning to keep the medication out of reach of children. Each sublingual tablet contains 10mg of Asenapine and has Phenylalanine, Magnesium, and Povidone as ingredients. Dosage information is not available. The tablets are for sublingual use only and should not be chewed or swallowed. The recommended storage temperature is 20°C to 25°C. The manufacturer's information is provided, and the packaging contains 60 unit-dose tablets.*
Principal Display Panel (10 mg Tablet Blister Pack Box)
This is a description of Asenapine Sublingual Tablets. Each tablet contains 5mg of asenapine as well as other ingredients. The tablets have a black cherry flavor, and they are intended for sublingual (under the tongue) use only. The package contains 60 unit-dose tablets. There are instructions on the other side of the package. The medication should be stored at a temperature between 68-77 degrees Fahrenheit. The package warns to keep the medication away from children.*
Asenapine 15
The text contains information about Asenapine sublingual tablets with black cherry flavor. The tablets come in unit-dose of 60 tablets and each tablet contains 10mg of Asenapine, magnesium stearate, povidons, aspartame, and black cherry flavor among other components. The dosage is not provided and the user should refer to the package insert for instructions. The storage temperature is 20-25°C, and the medication should be kept out of reach of children. The text also contains manufacturer and distributor information and cautions against using the medication through other routes of administration.*
Asenapine 16
This is a description of a medication called Asenapine Sublingual Tablets. The medication comes in a 60 unit-dose tablet pack with a recommended storage temperature of 20°C to 25°C. The tablets contain 25mg of asenapine and are intended for sublingual use. In addition to asenapine, the tablets consist of several components including phenylalanine and aspartame. The medication is flavored with black cherry flavor and should not be cut, chewed, or swallowed. The usage instructions and additional details can be found on the back of the package.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
