Neomycin And Polymyxin B Sulfates And Hydrocortisone Suspension
NDC Package 61314-641-75

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Neomycin And Polymyxin B Sulfates And Hydrocortisone (neomycin sulfate, polymyxin b sulfate and hydrocortisone) suspension is neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. This formulation utilizes a suspension delivery system. Marketed by Sandoz Inc, this product is identified by NDC 61314-641 and is authorized under FDA application ANDA062874.

Identification & Billing

NDC Package Code
61314-641-75
Package Description
7.5 mL in 1 BOTTLE, PLASTIC
Product Code
61314-641
11-Digit Billing Format
61314064175
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
7.5 ML
RxNorm Crosswalk
  • RxCUI: 204874 - neomycin sulfate 0.35 % / polymyxin B sulfate 10,000 UNT/ML / hydrocortisone 1 % Ophthalmic Suspension
  • RxCUI: 204874 - hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Suspension
  • RxCUI: 204874 - hydrocortisone 1 % / neomycin (neomycin sulfate) 0.35 % / polymyxin B (polymyxin B sulfate) 10,000 UNT/ML Ophthalmic Suspension

Clinical Specifications

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
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid 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 (See CLINICAL PHARMACOLOGY: Microbiology).The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.

Regulatory & Marketing

Labeler Name
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA062874
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-09-2003
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 61314-641-75 identifies a specific commercial package of 7.5 ml in 1 bottle, plastic of Neomycin And Polymyxin B Sulfates And Hydrocortisone, a human prescription drug labeled by Sandoz Inc. This suspension is formulated for ophthalmic use and contains hydrocortisone; neomycin sulfate; polymyxin b sulfate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sandoz Inc on May 09, 2003. The current certification is valid through December 31, 2026.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314064175. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 7.5 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
61314-641-75
11-Digit CMS (5-4-2)
61314-0641-75

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.