NDC 59148-019-71 Abilify Maintena

Aripiprazole

NDC Package Code 59148-019-71

The NDC Code 59148-019-71 is assigned to a package of 1 kit in 1 carton * 1.9 ml in 1 vial, single-use * 5 ml in 1 vial, single-use of Abilify Maintena, a human prescription drug labeled by Otsuka America Pharmaceutical, Inc.. The product's dosage form is kit and is administered via form.

The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 59148-019-71 is $2288.05668 and is up-to-date as of 10-13-2021.

Field Name Field Value
NDC Code 59148-019-71
Package Description 1 KIT in 1 CARTON * 1.9 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE
Proprietary Name Abilify Maintena 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.
Non-Proprietary Name Aripiprazole 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.
Drug Uses 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 59148001971 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.
Billing Unit EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk1602163, 1602171, 1602604, 1602607, 1659812, 1659814, 1659816 and 1659818 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug 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.
Labeler Name Otsuka America Pharmaceutical, Inc.
Dosage Form Kit - A packaged collection of related material.
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number NDA202971 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.
Start Marketing Date 02-28-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
Exclude Flag N 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".

NDC Code Structure

  • 59148 - Otsuka America Pharmaceutical, Inc.
    • 59148-019 - Abilify Maintena
      • 59148-019-71 - 1 KIT in 1 CARTON * 1.9 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE

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.

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National Average Drug Acquisition Cost (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average drug invoice price paid by retail community pharmacies to wholesalers. The Centers for Medicare and Medicaid Services (CMS) compile the NADAC data based on random monthly surveys on more than 60,000 pharmacies from all 50 states and the District of Columbia. NADAC pricing information is NOT the price paid by end-customers but instead the price paid by pharmacies to drug wholesalers and distributors.

Field Name Field Value
Price per Unit $2288.05668
Effective Date 01-15-2021 Effective Date
The effective date of the NADAC Per Unit cost.
Pricing Unit EA Pricing Unit
Indicates the pricing unit for the associated NDC (ML, GM or EA).
Pharmacy Type Indicator C/I - Chain or Independent Pharmacy Pharmacy Type Indicator
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Explanation Code Code 2: The average acquisition cost of the most recent survey was within ± 2% of the current NADAC; therefore, the NADAC was carried forward from the previous file. Explanation Code
The source of pharmacy survey data used to calculate the NADAC. 'C/I' indicates data was collected from surveys of Chain/Independent pharmacies. Other pharmacy type indicators are not used at this time.
Classification for Rate Setting B - Brand Classification for Rate Setting
Indicates whether the NDC was considered brand (B) or generic (G) for the NADAC rate calculation process. If the NDC was considered brand (B) and approved under an Abbreviated New Drug Application (ANDA), the indicator is shown as (B-ANDA).
As of Date 10-13-2021
View Pricing Details

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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 59148-019-71 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
59148001971J0401Inj aripiprazole ext rel 1mg1 MG11400400

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