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  5. NDC Package Code: 0078-0771-01 Maxitrol

NDC Package 0078-0771-01 Maxitrol

Neomycin Sulfate,Polymyxin B Sulfate And Dexamethasone Ointment 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:
0078-0771-01
Package Description:
3.5 g in 1 TUBE
Product Code:
0078-0771
Proprietary Name:
Maxitrol
Non-Proprietary Name:
Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone
Substance Name:
Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate
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.
11-Digit NDC Billing Format:
00078077101
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    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(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • DEXAMETHASONE 1 mg/g
  • NEOMYCIN SULFATE 3.5 mg/g
  • POLYMYXIN B SULFATE 10000 [USP'U]/g
    • 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:
    NDA050065
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-17-1972
    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 0078-0771-01?

    The NDC Packaged Code 0078-0771-01 is assigned to a package of 3.5 g in 1 tube of Maxitrol, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is ointment and is administered via ophthalmic form.

    Is NDC 0078-0771 included in the NDC Directory?

    Yes, Maxitrol with product code 0078-0771 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on January 17, 1972 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 11-digit format for NDC 0078-0771-01?

    The 11-digit format is 00078077101. 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 4-4-2 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
    4-4-20078-0771-015-4-200078-0771-01