Antibiotic
NDC Package 58988-0038-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Antibiotic is adults and children 2 years of age and older:clean the affected areaapply a small amount of this product (an amount equal to the surface area of the tip of a finer) on the area 1 to 3 times dailymay be covered with a sterile bandagechildren under 2 years of age:  ask a doctor. Marketed by Promex, Llc, this product is identified by NDC 58988-0038 and is authorized under FDA application part333B.

Identification & Billing

NDC Package Code
58988-0038-1
Package Description
1 TUBE in 1 BOX / 28.35 g in 1 TUBE
Product Code
58988-0038
11-Digit Billing Format
58988003801
RxNorm Crosswalk
  • RxCUI: 311928 - neomycin 0.35 % Topical Ointment
  • RxCUI: 311928 - neomycin 0.0035 MG/MG Topical Ointment
  • RxCUI: 311928 - neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical Ointment

Clinical Specifications

Proprietary Name
Antibiotic
Dosage Form
-
Usage Information
Adults and children 2 years of age and older:clean the affected areaapply a small amount of this product (an amount equal to the surface area of the tip of a finer) on the area 1 to 3 times dailymay be covered with a sterile bandagechildren under 2 years of age:  ask a doctor

Regulatory & Marketing

Labeler Name
Promex, Llc
FDA Application #
part333B
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
12-05-2013
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58988-0038-1 identifies a specific commercial package of 1 tube in 1 box / 28.35 g in 1 tube of Antibiotic, labeled by Promex, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Promex, Llc on December 05, 2013. The current certification is valid through December 31, 2017.

How is this Promex, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58988003801. 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 (5-4-1)
58988-0038-1
11-Digit CMS (5-4-2)
58988-0038-01

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