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  5. NDC Package Code: 12658-0614-1 Aripiprazole Lauroxil

NDC Package 12658-0614-1 Aripiprazole Lauroxil

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
12658-0614-1
Package Description:
9 kg in 1 DRUM
Product Code:
12658-0614
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:
12658061401
Product Type:
Bulk Ingredient
Labeler Name:
Pharmaceutical Works Polpharma
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • ARIPIPRAZOLE LAUROXIL 20 kg/20kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    10-05-2015
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Frequently Asked Questions

    What is NDC 12658-0614-1?

    The NDC Packaged Code 12658-0614-1 is assigned to an UNFINISHED drug package of 9 kg in 1 drum of Aripiprazole Lauroxil, a bulk ingredient labeled by Pharmaceutical Works Polpharma. The product's dosage form is powder and is administered via form.

    Is NDC 12658-0614 included in the NDC Directory?

    Yes, Aripiprazole Lauroxil is an UNFINISHED PRODUCT with code 12658-0614 that is active and included in the NDC Directory. The product was first marketed by Pharmaceutical Works Polpharma on October 05, 2015 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 12658-0614-1?

    The 11-digit format is 12658061401. 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 5-4-1 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
    5-4-112658-0614-15-4-212658-0614-01