NDC Package 28595-570-04 Spinosad

Suspension Topical - 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:
28595-570-04
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Spinosad
Non-Proprietary Name:
Spinosad
Substance Name:
Spinosad
Usage Information:
This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Head lice lay small white eggs (nits) at the roots of hair close to the scalp, especially on the hairline at the back of the neck and behind the ears. Spinosad works by paralyzing and killing lice and their eggs. This medication should not be used on infants younger than 6 months due to the increased risk for serious side effects.
11-Digit NDC Billing Format:
28595057004
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1085816 - spinosad 0.9 % Topical Suspension
  • RxCUI: 1085816 - spinosad 9 MG/ML Medicated Shampoo
  • RxCUI: 1085816 - spinosad 0.9 % Medicated Shampoo
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Allegis Pharmaceuticals, Llc
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA022408
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    06-25-2014
    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.

    Frequently Asked Questions

    What is NDC 28595-570-04?

    The NDC Packaged Code 28595-570-04 is assigned to a package of 1 bottle, plastic in 1 carton / 120 ml in 1 bottle, plastic of Spinosad, a human prescription drug labeled by Allegis Pharmaceuticals, Llc. The product's dosage form is suspension and is administered via topical form.

    Is NDC 28595-570 included in the NDC Directory?

    Yes, Spinosad with product code 28595-570 is active and included in the NDC Directory. The product was first marketed by Allegis Pharmaceuticals, Llc on June 25, 2014 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 28595-570-04?

    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 28595-570-04?

    The 11-digit format is 28595057004. 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
    5-3-228595-570-045-4-228595-0570-04