NDC Package 80425-0229-1 Neomycin And Polymyxin B Sulfates 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:
80425-0229-1
Package Description:
1 TUBE in 1 CARTON / 3.5 g in 1 TUBE
Product Code:
Proprietary Name:
Neomycin And Polymyxin B Sulfates And Dexamethasone
Non-Proprietary Name:
Neomycin And Polymyxin B Sulfates And Dexamethasone
Substance Name:
Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate
Usage Information:
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 steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid 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.The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.
11-Digit NDC Billing Format:
80425022901
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: 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
  • RxCUI: 309679 - dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic Ointment
Product Type:
Human Prescription Drug
Labeler Name:
Advanced Rx Pharmacy Of Tennessee, Llc
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:
ANDA064063
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
01-11-2023
Listing Expiration Date:
12-31-2025
Exclude Flag:
N

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.

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Frequently Asked Questions

What is NDC 80425-0229-1?

The NDC Packaged Code 80425-0229-1 is assigned to a package of 1 tube in 1 carton / 3.5 g in 1 tube of Neomycin And Polymyxin B Sulfates And Dexamethasone, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. The product's dosage form is ointment and is administered via ophthalmic form.This product is billed per "GM" gram and contains an estimated amount of 3.5 billable units per package.

Is NDC 80425-0229 included in the NDC Directory?

Yes, Neomycin And Polymyxin B Sulfates And Dexamethasone with product code 80425-0229 is active and included in the NDC Directory. The product was first marketed by Advanced Rx Pharmacy Of Tennessee, Llc on January 11, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 80425-0229-1?

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 80425-0229-1?

The 11-digit format is 80425022901. 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 5-4-1 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
5-4-180425-0229-15-4-280425-0229-01