NDC 62332-497 Lurasidone Hydrochloride

Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
62332-497
Proprietary Name:
Lurasidone Hydrochloride
Non-Proprietary Name: [1]
Lurasidone Hydrochloride
Substance Name: [2]
Lurasidone Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Alembic Pharmaceuticals Inc.
    Labeler Code:
    62332
    FDA Application Number: [6]
    ANDA213248
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-24-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF WHITE)
    GREEN (C48329 - PALE GREEN)
    Shape:
    ROUND (C48348)
    CAPSULE (C48336)
    OVAL (C48345)
    Size(s):
    6 MM
    8 MM
    13 MM
    12 MM
    Imprint(s):
    515;L
    516;L
    L551
    L517
    Score:
    1

    Product Packages

    NDC Code 62332-497-10

    Package Description: 100 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

    NDC Code 62332-497-30

    Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.50801 per EA

    NDC Code 62332-497-71

    Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 62332-497-90

    Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 62332-497-91

    Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

    Product Details

    What is NDC 62332-497?

    The NDC code 62332-497 is assigned by the FDA to the product Lurasidone Hydrochloride which is a human prescription drug product labeled by Alembic Pharmaceuticals Inc.. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 62332-497-10 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 62332-497-30 30 tablet, film coated in 1 bottle , 62332-497-71 500 tablet, film coated in 1 bottle , 62332-497-90 90 tablet, film coated in 1 bottle , 62332-497-91 1000 tablet, film coated in 1 bottle . 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 Lurasidone Hydrochloride?

     Lurasidone hydrochloride tablets are indicated for:Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].

    What are Lurasidone Hydrochloride 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.
    • LURASIDONE HYDROCHLORIDE 80 mg/1 - A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic α2A and α2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.

    Which are Lurasidone Hydrochloride UNII Codes?

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

    Which are Lurasidone Hydrochloride 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 Lurasidone Hydrochloride?

    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:

    Which are the Pharmacologic Classes for Lurasidone Hydrochloride?

    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

    Lurasidone


    Lurasidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and children 13 years of age and older. It is also used to treat depression in adults and children 10 years of age and older with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Lurasidone is also used along with lithium (Lithobid) or valproate (Depacon) to treat depression in adults with bipolar disorder. Lurasidone 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".