Vitacilina Neomycin Sulfate First Aid Antibiotic Ointment
NDC Package 54312-019-35

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

Package Information

Vitacilina Neomycin Sulfate First Aid Antibiotic (neomycin sulfate) ointment is a medication used to decrease the risk of infection after certain intestinal surgeries. This formulation utilizes a ointment delivery system. Marketed by Compania Internacional De Comercio, S.a.p.i De C.v., this product is identified by NDC 54312-019 and is authorized under FDA application M004.

Identification & Billing

NDC Package Code
54312-019-35
Package Description
1 TUBE in 1 CARTON / 14 g in 1 TUBE
Product Code
54312-019
11-Digit Billing Format
54312001935
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vitacilina Neomycin Sulfate First Aid Antibiotic
Non-Proprietary Name
Neomycin Sulfate
Substance Name
Neomycin 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
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
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.

Regulatory & Marketing

Labeler Name
Compania Internacional De Comercio, S.a.p.i De C.v.
Product Type
Human Otc Drug
FDA Application #
M004
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-30-2016
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54312-019). Click a package code to view its specific billing and regulatory data.

54312-019-31
1 TUBE in 1 CARTON / 28 g in 1 TUBE

* 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 54312-019-35 identifies a specific commercial package of 1 tube in 1 carton / 14 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.. This ointment is formulated for topical use and contains neomycin 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 Compania Internacional De Comercio, S.a.p.i De C.v. on July 30, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Compania Internacional De Comercio, S.a.p.i De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54312001935. 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 (5-3-2)
54312-019-35
11-Digit CMS (5-4-2)
54312-0019-35

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