NDC Package 0078-0876-01 Tobradex

Tobramycin And Dexamethasone Ointment Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

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:
0078-0876-01
Package Description:
3.5 g in 1 TUBE
Product Code:
Proprietary Name:
Tobradex
Non-Proprietary Name:
Tobramycin And Dexamethasone
Substance Name:
Dexamethasone; Tobramycin
Usage Information:
This medication is used to treat or prevent eye infections. This medication contains two drugs. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. Dexamethasone belongs to a class of drugs called corticosteroids. It works by reducing swelling. This medication treats/prevents only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
11-Digit NDC Billing Format:
00078087601
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
3.5 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 208821 - TobraDex 0.3 % / 0.1 % Ophthalmic Ointment
  • RxCUI: 208821 - dexamethasone 0.001 MG/MG / tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobradex]
  • RxCUI: 208821 - Tobradex (tobramycin 0.3 % / dexamethasone 0.1 % ) Ophthalmic Ointment
  • RxCUI: 309682 - tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Ointment
  • RxCUI: 309682 - dexamethasone 0.001 MG/MG / tobramycin 0.003 MG/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.
  • Sample Package:
    No
    FDA Application Number:
    NDA050616
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-15-1988
    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 0078-0876-01?

    The NDC Packaged Code 0078-0876-01 is assigned to a package of 3.5 g in 1 tube of Tobradex, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is ointment and is administered via ophthalmic form.

    Is NDC 0078-0876 included in the NDC Directory?

    Yes, Tobradex with product code 0078-0876 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on October 15, 1988 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 0078-0876-01?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 3.5.

    What is the 11-digit format for NDC 0078-0876-01?

    The 11-digit format is 00078087601. 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
    4-4-20078-0876-015-4-200078-0876-01