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  5. NDC Package Code: 61314-630-06 Neomycin And Polymyxin B Sulfates And Dexamethasone

NDC Package 61314-630-06 Neomycin And Polymyxin B Sulfates And Dexamethasone

Neomycin Sulfate,Polymyxin B Sulfate And Dexamethasone Suspension Ophthalmic - 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:
61314-630-06
Package Description:
5 mL in 1 BOTTLE, PLASTIC
Product Code:
61314-630
Proprietary Name:
Neomycin And Polymyxin B Sulfates And Dexamethasone
Non-Proprietary Name:
Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone
Substance Name:
Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate
Usage Information:
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.Ocular corticosteroids are indicated in inflammatory conditions of the papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.This product does not provide adequate coverage against: Serratia marcesens and streptococci, including Streptococcus pneumoniae.
11-Digit NDC Billing Format:
61314063006
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
5 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 309680 - neomycin sulfate 3.5 MG/ML / polymyxin B sulfate 10,000 UNT/mL / dexAMETHasone 0.1 % Ophthalmic Suspension
  • RxCUI: 309680 - dexamethasone 1 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Suspension
  • RxCUI: 309680 - dexamethasone 0.1 % / neomycin 0.35 % / polymyxin B 10,000 UNT per ML Ophthalmic Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • DEXAMETHASONE 1 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:
    ANDA062341
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-21-1996
    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 61314-630-06?

    The NDC Packaged Code 61314-630-06 is assigned to a package of 5 ml in 1 bottle, plastic of Neomycin And Polymyxin B Sulfates And Dexamethasone, a human prescription drug labeled by Sandoz Inc.. The product's dosage form is suspension and is administered via ophthalmic form.

    Is NDC 61314-630 included in the NDC Directory?

    Yes, Neomycin And Polymyxin B Sulfates And Dexamethasone with product code 61314-630 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc. on February 21, 1996 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 61314-630-06?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 5.

    What is the 11-digit format for NDC 61314-630-06?

    The 11-digit format is 61314063006. 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
    5-3-261314-630-065-4-261314-0630-06