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  5. NDC Package Code: 54312-019-31 Vitacilina Neomycin Sulfate First Aid Antibiotic

NDC Package 54312-019-31 Vitacilina Neomycin Sulfate First Aid Antibiotic

Neomycin Sulfate Ointment Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
54312-019-31
Package Description:
1 TUBE in 1 CARTON / 28 g in 1 TUBE
Product Code:
54312-019
Proprietary Name:
Vitacilina Neomycin Sulfate First Aid Antibiotic
Non-Proprietary Name:
Neomycin Sulfate
Substance Name:
Neomycin Sulfate
Usage Information:
This medication is used to decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
11-Digit NDC Billing Format:
54312001931
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Compania Internacional De Comercio, S.a.p.i De C.v.
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):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s):
NEOMYCIN SULFATE 3.5 mg/g
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
M004
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
07-30-2016
Listing Expiration Date:
12-31-2026
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
54312-019-351 TUBE in 1 CARTON / 14 g in 1 TUBE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 54312-019-31?

The NDC Packaged Code 54312-019-31 is assigned to a package of 1 tube in 1 carton / 28 g in 1 tube of Vitacilina Neomycin Sulfate First Aid Antibiotic, a human over the counter drug labeled by Compania Internacional De Comercio, S.a.p.i De C.v.. The product's dosage form is ointment and is administered via topical form.

Is NDC 54312-019 included in the NDC Directory?

Yes, Vitacilina Neomycin Sulfate First Aid Antibiotic with product code 54312-019 is active and included in the NDC Directory. The product was first marketed by Compania Internacional De Comercio, S.a.p.i De C.v. on July 30, 2016 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 54312-019-31?

The 11-digit format is 54312001931. 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 5-3-2 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
5-3-254312-019-315-4-254312-0019-31