Invega Sustenna Injection
Product Images NDC 50458-564

20 FDA label images from Janssen Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Invega Sustenna (NDC 50458-564). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen 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

Figure (Invega 01)

Figure (Invega 01)
An instructional illustration showing a prefilled syringe with labeled components including a 22-gauge by 1½ inch gray hub and a 23-gauge by 1 inch blue hub with a tip cap. The diagram highlights the syringe parts relevant for injection preparation or administration.*
FDA Label Image

Figure (Invega 02)

Figure (Invega 02)
An instructional illustration showing a hand holding a syringe with the thumb on the plunger and fingers gripping the barrel, demonstrating how to push and pull the plunger of the syringe, likely to prepare the paliperidone palmitate injection (INVEGA SUSTENNA).*
FDA Label Image

Figure (Invega 03)

Figure (Invega 03)
An instructional illustration showing two hands preparing an injectable medication. One hand holds a vial or syringe and is twisting off the cap or needle cover while the other hand steadies the syringe below. The image suggests correct preparation technique for an intramuscular injection, likely for INVEGA SUSTENNA (paliperidone palmitate).*
FDA Label Image

Figure (Invega 04)

Figure (Invega 04)
An instructional diagram showing two hands preparing an injection syringe. The image depicts one hand holding a vial or syringe while the other hand rotates the vial or cap, illustrating a step in the preparation of an intramuscular injection, likely for the drug INVEGA SUSTENNA (paliperidone palmitate).*
FDA Label Image

Figure (Invega 05)

Figure (Invega 05)
An instructional illustration showing hands removing a cap from a vial or prefilled syringe. The image demonstrates the first step in preparing an injection, likely related to the administration of INVEGA SUSTENNA (paliperidone palmitate) intramuscular injection.*
FDA Label Image

Figure (Invega 06)

Figure (Invega 06)
An instructional diagram showing a pair of hands holding a syringe with a needle cap being removed, indicating preparation for intramuscular injection. The illustration is related to the administration of INVEGA SUSTENNA (paliperidone palmitate) injection.*
FDA Label Image

H1 (Invega 07)

H1 (Invega 07)
An instructional diagram showing a hand holding a syringe with a protective cap being removed by pulling it away from the syringe tip, indicated by an arrow. The syringe depicted is consistent with an injection dosage form such as INVEGA SUSTENNA.*
FDA Label Image

H2 (Invega 08)

H2 (Invega 08)
An instructional line drawing showing a hand holding a syringe, with an arrow indicating the removal or positioning of a needle cap or similar component on the syringe, related to the administration of the INVEGA SUSTENNA injection.*
FDA Label Image

H3 (Invega 09)

H3 (Invega 09)
Illustration showing a hand pressing the plunger of a syringe, with the needle covered by a protective cap, demonstrating the proper technique for preparing an intramuscular injection.*
FDA Label Image

Chemical Structure (Invega 10)

Chemical Structure (Invega 10)
Chemical structure of the active ingredient paliperidone palmitate, shown as a molecular diagram with distinct rings and functional groups illustrating its detailed chemical composition.*
FDA Label Image

Figure 1 (Invega 11)

Figure 1 (Invega 11)
A chart illustrating the fold change and 90% confidence interval for paliperidone's AUC and Cmax when interacting with CYP2D6 inhibitor (Paroxetine), CYP3A4 inducer (Carbamazepine), and Divalproex Sodium ER, with changes relative to a reference standard without interacting drugs. The x-axis displays change relative to reference values.*
FDA Label Image

Figure 2 (Invega 12)

Figure 2 (Invega 12)
A pharmacokinetic chart showing the effect of intrinsic factors on paliperidone exposure, depicting paliperidone fold change with 90% confidence intervals. Factors include renal impairment (mild, moderate, severe vs normal), hepatic impairment (moderate vs normal), and age (18-64 vs over 65 years). The chart compares changes in AUC and Cmax relative to reference values.*
FDA Label Image

Figure 3 (Invega 13)

Figure 3 (Invega 13)
A Kaplan-Meier survival curve graph showing the estimated percent of subjects with relapse over time since randomization, comparing INVEGA SUSTENNA injection to placebo. The graph illustrates a lower relapse rate for the INVEGA SUSTENNA group compared to the placebo group over approximately 280 days.*
FDA Label Image

Figure 4 (Invega 13a)

Figure 4 (Invega 13a)
A Kaplan-Meier curve comparing estimated percent of subjects with treatment failure over time between INVEGA SUSTENNA injection and oral antipsychotic treatment groups. The x-axis represents days since randomization up to 450 days, and the y-axis shows the estimated percent with treatment failure. Two lines depict treatment failure rates for INVEGA SUSTENNA (solid line) and oral antipsychotic (dashed line).*
FDA Label Image

Figure 4 (Invega 14)

Figure 4 (Invega 14)
A Kaplan-Meier curve showing the estimated percent of subjects with relapse over days since randomization. The graph compares placebo (N=170) versus INVEGA SUSTENNA (N=164), illustrating a lower relapse rate in subjects treated with INVEGA SUSTENNA over approximately 450 days.*
FDA Label Image

Principal Display Panel (39 mg Syringe Carton)

Principal Display Panel (39 mg Syringe Carton)
Packaging label for INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable suspension, 39 mg/0.25 mL. The label indicates a single-dose prefilled syringe for intramuscular injection, labeled by Janssen Pharmaceuticals, Inc. Storage instructions specify room temperature (77°F, 25°C), with temperature excursion allowances. The package includes safety needle information and warnings for healthcare professional use only.*
FDA Label Image

Principal Display Panel (78 mg Syringe Carton)

Principal Display Panel (78 mg Syringe Carton)
Packaging label for INVEGA SUSTENNA 78 mg/0.5 mL extended-release injectable suspension (paliperidone palmitate) by Janssen Pharmaceuticals, Inc. The label indicates a single-dose prefilled syringe for intramuscular injection only, includes storage instructions, and notes that the package contains one syringe and two needles. It emphasizes shaking before use and prescription-only status.*
FDA Label Image

Principal Display Panel (117 mg Syringe Carton)

Principal Display Panel (117 mg Syringe Carton)
INVEGA SUSTENNA 117 mg/0.75 mL extended-release injectable suspension label for intramuscular injection. The label states the active ingredient paliperidone palmitate and indicates a single-dose prefilled syringe with two needles included. It cautions to store at room temperature (77°F, 25°C) with specified excursions and specifies use by healthcare professionals. The labeler is Janssen Pharmaceuticals, Inc.*
FDA Label Image

Principal Display Panel (156 mg Syringe Carton)

Principal Display Panel (156 mg Syringe Carton)
Box packaging label for INVEGA SUSTENNA 156 mg/mL (paliperidone palmitate) extended-release injectable suspension. The label indicates a single-dose prefilled syringe for intramuscular injection only, manufactured by Janssen Pharmaceuticals, Inc. It provides storage instructions at room temperature and includes usage and contents information.*
FDA Label Image

Principal Display Panel (234 mg Syringe Carton)

Principal Display Panel (234 mg Syringe Carton)
Packaging label for INVEGA SUSTENNA 234 mg/1.5 mL extended-release injectable suspension of paliperidone palmitate. The label indicates a single-dose prefilled syringe for intramuscular injection only, with contents including one syringe and two needles. Storage instructions specify room temperature. Labeler is Janssen Pharmaceuticals, Inc.*

* 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.