Neomycin And Polymyxin B Sulfates And Hydrocortisone Suspension
NDC Package 61314-645-11

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 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. This formulation utilizes a suspension delivery system. Marketed by Sandoz Inc., this product is identified by NDC 61314-645 and is authorized under FDA application ANDA062488.

Identification & Billing

NDC Package Code
61314-645-11
Package Description
10 mL in 1 BOTTLE, PLASTIC
Product Code
61314-645
11-Digit Billing Format
61314064511
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
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

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
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Sandoz Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA062488
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-17-2003
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 61314-645-11 identifies a specific commercial package of 10 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 auricular (otic) 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 March 17, 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: 61314064511. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 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)
61314-645-11
11-Digit CMS (5-4-2)
61314-0645-11

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