Aristada Injection, Suspension, Extended Release
NDC Package 65757-404-03

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

Package Information

Aristada (aripiprazole lauroxil) injection is extended-release aripiprazole injection is used to treat a mental/mood disorder called schizophrenia. This formulation utilizes a injection, suspension, extended release delivery system. Marketed by Alkermes, Inc., this product is identified by NDC 65757-404 and is authorized under FDA application NDA207533.

Identification & Billing

NDC Package Code
65757-404-03
Package Description
1 SYRINGE in 1 CARTON / 3.9 mL in 1 SYRINGE
Product Code
65757-404
11-Digit Billing Format
65757040403
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1673269 - ARIPiprazole lauroxil 441 MG in 1.6 ML Prefilled Syringe
  • RxCUI: 1673269 - 1.6 ML aripiprazole lauroxil 276 MG/ML Prefilled Syringe
  • RxCUI: 1673269 - aripiprazole lauroxil 441 MG per 1.6 ML Extended Release Suspension Prefilled Syringe
  • RxCUI: 1673269 - aripiprazole lauroxil 441 MG per 1.6 ML Prefilled Syringe
  • RxCUI: 1673274 - Aristada 441 MG in 1.6 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Aristada
Non-Proprietary Name
Aripiprazole Lauroxil
Substance Name
Aripiprazole Lauroxil
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)
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Extended-release aripiprazole injection is used to treat a mental/mood disorder called schizophrenia. This medication can decrease hallucinations (hearing/seeing things that are not there) and improve your concentration. It also helps you to think more clearly, feel less nervous, and take a more active part in everyday life. Some brands of this medication are also used to treat bipolar disorder. It can help to decrease extreme changes in mood and help you feel less agitated. Extended-release aripiprazole injection is a long-acting psychiatric medication known as an atypical antipsychotic. It works by helping to restore the balance of certain natural substances in the brain.

Regulatory & Marketing

Labeler Name
Alkermes, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA207533
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-05-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1942
Source: PDAC
INJECTION, ARIPIPRAZOLE LAUROXIL, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (65757-404). Click a package code to view its specific billing and regulatory data.

65757-404-00
20 TRAY in 1 CARTON / 15 SYRINGE in 1 TRAY / 3.9 mL in 1 SYRINGE
65757-404-04
1 SYRINGE in 1 CARTON / 3.9 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 65757-404-03 identifies a specific commercial package of 1 syringe in 1 carton / 3.9 ml in 1 syringe of Aristada, a human prescription drug labeled by Alkermes, Inc.. This injection, suspension, extended release is formulated for intramuscular use and contains aripiprazole lauroxil 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 Alkermes, Inc. on June 05, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Extended-release aripiprazole injection is used to treat a mental/mood disorder called schizophrenia. This medication can decrease hallucinations (hearing/seeing things that are not there) and improve your concentration. It also helps you to think more clearly, feel less nervous, and take a more active part in everyday life. Some brands of this medication are also used to treat bipolar disorder. It can help to decrease extreme changes in mood and help you feel less agitated. Extended-release aripiprazole injection is a long-acting psychiatric medication known as an atypical antipsychotic. It works by helping to restore the balance of certain natural substances in the brain.

How is this Alkermes, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65757040403. 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)
65757-404-03
11-Digit CMS (5-4-2)
65757-0404-03

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