NDC 50458-561 Invega Sustenna

Paliperidone Palmitate Injection Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
50458-561
Proprietary Name:
Invega Sustenna
Non-Proprietary Name: [1]
Paliperidone Palmitate
Substance Name: [2]
Paliperidone Palmitate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Labeler Name: [5]
    Janssen Pharmaceuticals, Inc.
    Labeler Code:
    50458
    FDA Application Number: [6]
    NDA022264
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-31-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 50458-561-01

    Package Description: 1 SYRINGE in 1 KIT / .5 mL in 1 SYRINGE

    Price per Unit: $2225.59729 per ML

    Product Details

    What is NDC 50458-561?

    The NDC code 50458-561 is assigned by the FDA to the product Invega Sustenna which is a human prescription drug product labeled by Janssen Pharmaceuticals, Inc.. The generic name of Invega Sustenna is paliperidone palmitate. The product's dosage form is injection and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 50458-561-01 1 syringe in 1 kit / .5 ml in 1 syringe. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Invega Sustenna?

    This medication is used to treat certain mental/mood disorders (such as schizophrenia, schizoaffective disorder). Paliperidone is an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals (neurotransmitters) in the brain. This medication can decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.

    What are Invega Sustenna Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • PALIPERIDONE PALMITATE 78 mg/.5mL - A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.

    Which are Invega Sustenna UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Invega Sustenna Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Invega Sustenna?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 858048 - paliperidone palmitate 78 in 0.5 ML Prefilled Syringe
    • RxCUI: 858048 - 0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe
    • RxCUI: 858048 - paliperidone palmitate 78 MG per 0.5 ML Prefilled Syringe
    • RxCUI: 858051 - Invega Sustenna 78 MG in 0.5 mL Prefilled Syringe
    • RxCUI: 858051 - 0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe [Invega]

    Which are the Pharmacologic Classes for Invega Sustenna?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Paliperidone Injection


    Paliperidone extended-release injections (Invega Hafyera, Invega Sustenna, Invega Trinza) are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Paliperidone extended-release injection (Invega Sustenna) is also used alone or with other medications to treat schizoaffective disorder (a mental illness that causes both a loss of contact with reality and mood problems [depression or mania]). Paliperidone extended-release injection is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".