NDC Package 65757-404-03 Aristada

Aripiprazole Lauroxil Injection, Suspension, Extended Release Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65757-404-03
Package Description:
1 SYRINGE in 1 CARTON / 3.9 mL in 1 SYRINGE
Product Code:
Proprietary Name:
Aristada
Non-Proprietary Name:
Aripiprazole Lauroxil
Substance Name:
Aripiprazole Lauroxil
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.
11-Digit NDC Billing Format:
65757040403
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alkermes, Inc.
    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):
  • Intramuscular - Administration within a muscle.
  • Sample Package:
    No
    FDA Application Number:
    NDA207533
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-05-2017
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    65757-404-0020 TRAY in 1 CARTON / 15 SYRINGE in 1 TRAY / 3.9 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65757-404-03?

    The NDC Packaged Code 65757-404-03 is assigned to a package of 1 syringe in 1 carton / 3.9 ml in 1 syringe of Aristada, a human prescription drug labeled by Alkermes, Inc.. The product's dosage form is injection, suspension, extended release and is administered via intramuscular form.

    Is NDC 65757-404 included in the NDC Directory?

    Yes, Aristada with product code 65757-404 is active and included in the NDC Directory. The product was first marketed by Alkermes, Inc. on June 05, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65757-404-03?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 65757-404-03?

    The 11-digit format is 65757040403. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-265757-404-035-4-265757-0404-03