Maxitrol Ointment
NDC Package 0078-0771-01

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

Package Information

Maxitrol (neomycin sulfate, polymyxin b sulfate and dexamethasone) ointment is a medication used to treat conditions involving swelling (inflammation) of the eyes and to treat or prevent bacterial eye infections. This formulation utilizes a ointment delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0771 and is authorized under FDA application NDA050065.

Identification & Billing

NDC Package Code
0078-0771-01
Package Description
3.5 g in 1 TUBE
Product Code
0078-0771
11-Digit Billing Format
00078077101
RxNorm Crosswalk
  • RxCUI: 208601 - Maxitrol 1 MG / 3.5 MG / 10,000 UNT per GM Ophthalmic Ointment
  • RxCUI: 208601 - dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Maxitrol]
  • RxCUI: 208601 - Maxitrol (neomycin 3.5 MG / polymyxin b 10,000 UNT / dexamethasone 1 MG) per GM Ophthalmic Ointment
  • RxCUI: 309679 - dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment
  • RxCUI: 309679 - dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment

Clinical Specifications

Proprietary Name
Maxitrol
Non-Proprietary Name
Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone
Substance Name
Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is used to treat conditions involving swelling (inflammation) of the eyes and to treat or prevent bacterial eye infections. This product contains neomycin and polymyxin, antibiotics that work by stopping the growth of bacteria. It also contains dexamethasone, an anti-inflammatory corticosteroid that works by reducing swelling. This medication treats/prevents only bacterial eye infections. It will not work for other types of eye infections and may worsen them (e.g., infections caused by viruses, fungi, mycobacteria). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA050065
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-17-1972
End Marketing Date
02-28-2027
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 0078-0771-01 identifies a specific commercial package of 3.5 g in 1 tube of Maxitrol, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This ointment is formulated for ophthalmic use and contains dexamethasone; 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 Novartis Pharmaceuticals Corporation on January 17, 1972.

What are the primary indications for this medication?

This medication is used to treat conditions involving swelling (inflammation) of the eyes and to treat or prevent bacterial eye infections. This product contains neomycin and polymyxin, antibiotics that work by stopping the growth of bacteria. It also contains dexamethasone, an anti-inflammatory corticosteroid that works by reducing swelling. This medication treats/prevents only bacterial eye infections. It will not work for other types of eye infections and may worsen them (e.g., infections caused by viruses, fungi, mycobacteria). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078077101. 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 (4-4-2)
0078-0771-01
11-Digit CMS (5-4-2)
00078-0771-01

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