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  5. NDC Package Code: 64980-448-01 Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic Suspension

NDC Package 64980-448-01 Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic Suspension

Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic Suspension Auricular (otic) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
64980-448-01
Package Description:
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code:
64980-448
Proprietary Name:
Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic Suspension
Non-Proprietary Name:
Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic
Substance Name:
Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate
Usage Information:
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.
11-Digit NDC Billing Format:
64980044801
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 310687 - hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic Suspension
  • RxCUI: 310687 - hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic Suspension
  • RxCUI: 310687 - hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rising Pharma Holdings, Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Auricular (otic) - Administration to or by way of the ear.
    • Active Ingredient(s):
  • HYDROCORTISONE 10 mg/mL
  • NEOMYCIN SULFATE 3.5 mg/mL
  • POLYMYXIN B SULFATE 10000 [USP'U]/mL
    • Pharmacologic Class(es):
  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Polymyxins - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA060613
    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:
    03-15-2019
    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 64980-448-01?

    The NDC Packaged Code 64980-448-01 is assigned to a package of 1 bottle in 1 carton / 10 ml in 1 bottle of Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic Suspension, a human prescription drug labeled by Rising Pharma Holdings, Inc.. The product's dosage form is suspension and is administered via auricular (otic) form.

    Is NDC 64980-448 included in the NDC Directory?

    Yes, Neomycin And Polymyxin B Sulfates And Hydrocortisone Otic Suspension with product code 64980-448 is active and included in the NDC Directory. The product was first marketed by Rising Pharma Holdings, Inc. on March 15, 2019 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 64980-448-01?

    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 64980-448-01?

    The 11-digit format is 64980044801. 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
    5-3-264980-448-015-4-264980-0448-01