1. Home
  2. Labeler Index
  3. Otsuka America Pharmaceutical, Inc
  4. NDC Product Code: 59148-102 Abilify Asimtufii

NDC 59148-102 Abilify Asimtufii

Aripiprazole Injection, Suspension, Extended Release Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 59148-102?
  4. Abilify Asimtufii Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

NDC Product Code:
59148-102
Proprietary Name:
Abilify Asimtufii
Non-Proprietary Name: [1]
Aripiprazole
Substance Name: [2]
Aripiprazole
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Suspension, Extended Release - A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Otsuka America Pharmaceutical, Inc
    Labeler Code:
    59148
    Product Label ID:
    da4c07fd-1130-4341-bb44-63acfa4162be
    FDA Application Number: [6]
    NDA217006
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-27-2023
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 59148-102?

    The NDC code 59148-102 is assigned by the FDA to the product Abilify Asimtufii which is a human prescription drug product labeled by Otsuka America Pharmaceutical, Inc. The generic name of Abilify Asimtufii is aripiprazole. The product's dosage form is injection, suspension, extended release and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 59148-102-80 1 syringe in 1 carton / 2.4 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 Abilify Asimtufii?

    Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazole is known as an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters). This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. Aripiprazole can treat severe mood swings and decrease how often mood swings occur.

    What are Abilify Asimtufii 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.
    • ARIPIPRAZOLE 720 mg/2.4mL - A piperazine and quinolone derivative that is used primarily as an antipsychotic agent. It is a partial agonist of SEROTONIN RECEPTOR, 5-HT1A and DOPAMINE D2 RECEPTORS, where it also functions as a post-synaptic antagonist, and an antagonist of SEROTONIN RECEPTOR, 5-HT2A. It is used for the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER, and as an adjunct therapy for the treatment of depression.

    Which are Abilify Asimtufii UNII Codes?

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

    Which are Abilify Asimtufii 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 Abilify Asimtufii?

    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: 2636637 - ARIPiprazole 720 MG in 2.4 ML Extended Release Prefilled Syringe
    • RxCUI: 2636637 - 2.4 ML aripiprazole 300 MG/ML Prefilled Syringe
    • RxCUI: 2636637 - aripiprazole 720 MG per 2.4 ML extended release Prefilled Syringe
    • RxCUI: 2636640 - Abilify Asimtufii 720 MG in 2.4 ML Extended Release Prefilled Syringe
    • RxCUI: 2636640 - 2.4 ML aripiprazole 300 MG/ML Prefilled Syringe [Abilify]

    Which are the Pharmacologic Classes for Abilify Asimtufii?

    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.

    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".