Polymyxin B Sulfate And Trimethoprim Sulfate Solution/ Drops
NDC Package 70518-4381-0

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

Package Information

Polymyxin B Sulfate And Trimethoprim Sulfate solution/ dropses is polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.**Efficacy for this organism in this organ system was studied in fewer than 10 infections. This formulation utilizes a solution/ drops delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4381 and is authorized under FDA application ANDA211572.

Identification & Billing

NDC Package Code
70518-4381-0
Package Description
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code
70518-4381
11-Digit Billing Format
70518438100
RxNorm Crosswalk
  • RxCUI: 244967 - polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution
  • RxCUI: 244967 - polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution
  • RxCUI: 244967 - polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution
  • RxCUI: 244967 - polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution
  • RxCUI: 244967 - Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution

Clinical Specifications

Proprietary Name
Polymyxin B Sulfate And Trimethoprim Sulfate
Non-Proprietary Name
Polymyxin B Sulfate And Trimethoprim Sulfate
Substance Name
Polymyxin B Sulfate; Trimethoprim
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.**Efficacy for this organism in this organ system was studied in fewer than 10 infections.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211572
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-4381-0 identifies a specific commercial package of 1 bottle in 1 carton / 10 ml in 1 bottle of Polymyxin B Sulfate And Trimethoprim Sulfate, a human prescription drug labeled by Remedyrepack Inc.. This solution/ drops is formulated for ophthalmic use and contains polymyxin b sulfate; trimethoprim 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 Remedyrepack Inc. on July 01, 2025. The current certification is valid through December 31, 2026.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518438100. 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)
70518-4381-0
11-Digit CMS (5-4-2)
70518-4381-00

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