NDC 65757-403-03 Aristada
Aripiprazole Lauroxil Injection, Suspension, Extended Release Intramuscular

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

The table below has 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 65757-403-03
Package Description 1 SYRINGE in 1 CARTON / 3.2 mL in 1 SYRINGE
Product Code 65757-403
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Aristada
Non-Proprietary Name 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.		 Aripiprazole Lauroxil
Substance Name 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.		 Aripiprazole Lauroxil
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 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 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 65757040303
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NADAC Wholesale Price per Unit National Average Drug Acquisition Cost (NADAC)
The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 65757-403-03 is $897.15340 and is up-to-date as of 05-31-2023. This product is billed per "ML" milliliter and contains an estimated amount of billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $		 $897.15340
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 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.    		 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.
    Active Ingredient(s)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.    		 No
    Marketing Category 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.    		 NDA - A product marketed under an approved New Drug Application.
    FDA Application Number 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.    		 NDA207533
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.    		 10-05-2015
    Listing Expiration Date 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.    		 12-31-2023
    Exclude Flag 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".     		N
    NDC 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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 65757-403-03 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    65757040303J1944Aripiprazole lauroxil 1 mg1 MG3.21882882

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for Aristada with product NDC 65757-403.

    NDC Package CodePackage Description
    65757-403-0020 TRAY in 1 CARTON / 15 SYRINGE in 1 TRAY / 3.2 mL in 1 SYRINGE
    65757-403-041 SYRINGE in 1 CARTON / 3.2 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65757-403-03?

    The NDC Packaged Code 65757-403-03 is assigned to a package of 1 syringe in 1 carton / 3.2 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 65757-403 included in the NDC Directory?

    Yes, Aristada with product code 65757-403 is active and included in the NDC Directory. The product was first marketed by Alkermes, Inc. on October 05, 2015 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65757-403-03?

    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 65757-403-03?

    The 11-digit format is 65757040303. 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 Package Format10-Digit Original Package Code11-Digit Package Format11-Digit Conversion Package Code
    5-3-265757-403-035-4-265757-0403-03