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  5. NDC Package Code: 61314-646-10 Neomycin And Polymyxin B Sulfates And Hydrocortisone

NDC Package 61314-646-10 Neomycin And Polymyxin B Sulfates And Hydrocortisone

Neomycin Sulfate,Polymyxin B Sulfate And Hydrocortisone Solution 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:
61314-646-10
Package Description:
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code:
61314-646
Proprietary Name:
Neomycin And Polymyxin B Sulfates And Hydrocortisone
Non-Proprietary Name:
Neomycin Sulfate, Polymyxin B Sulfate And Hydrocortisone
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.
11-Digit NDC Billing Format:
61314064610
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 204423 - neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Otic Solution
  • RxCUI: 204423 - hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic Solution
  • RxCUI: 204423 - hydrocortisone 1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML Otic Solution
  • RxCUI: 204423 - hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per ML Otic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    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 [iU]/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:
    ANDA062423
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-18-2003
    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 61314-646-10?

    The NDC Packaged Code 61314-646-10 is assigned to a package of 1 bottle in 1 carton / 10 ml in 1 bottle of Neomycin And Polymyxin B Sulfates And Hydrocortisone, a human prescription drug labeled by Sandoz Inc. The product's dosage form is solution and is administered via auricular (otic) form.

    Is NDC 61314-646 included in the NDC Directory?

    Yes, Neomycin And Polymyxin B Sulfates And Hydrocortisone with product code 61314-646 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on March 18, 2003 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 61314-646-10?

    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 61314-646-10?

    The 11-digit format is 61314064610. 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
    5-3-261314-646-105-4-261314-0646-10