Abilify Asimtufii Injection, Suspension, Extended Release
NDC Package 59148-114-92

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Abilify Asimtufii (aripiprazole) injection is aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). This formulation utilizes a injection, suspension, extended release delivery system. Marketed by Otsuka America Pharmaceutical, Inc, this product is identified by NDC 59148-114 and is authorized under FDA application NDA217006.

Identification & Billing

NDC Package Code
59148-114-92
Package Description
1 SYRINGE in 1 CARTON / 3.2 mL in 1 SYRINGE
Product Code
59148-114
11-Digit Billing Format
59148011492
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Abilify Asimtufii
Non-Proprietary Name
Aripiprazole
Substance Name
Aripiprazole
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
ARIPIPRAZOLE 960 mg/3.2mL
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
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.

Regulatory & Marketing

Labeler Name
Otsuka America Pharmaceutical, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA217006
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-27-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (59148-114). Click a package code to view its specific billing and regulatory data.

59148-114-80
1 SYRINGE in 1 CARTON / 3.2 mL in 1 SYRINGE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 59148-114-92 identifies a specific commercial package of 1 syringe in 1 carton / 3.2 ml in 1 syringe of Abilify Asimtufii, a human prescription drug labeled by Otsuka America Pharmaceutical, Inc. This injection, suspension, extended release is formulated for intramuscular use and contains aripiprazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Otsuka America Pharmaceutical, Inc on April 27, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Otsuka America Pharmaceutical, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59148011492. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
59148-114-92
11-Digit CMS (5-4-2)
59148-0114-92

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.