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  5. NDC Package Code: 70069-311-01 Polymyxin B Sulfate And Trimethoprim Sulfate

NDC Package 70069-311-01 Polymyxin B Sulfate And Trimethoprim Sulfate

Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
70069-311-01
Package Description:
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code:
70069-311
Proprietary Name:
Polymyxin B Sulfate And Trimethoprim Sulfate
Non-Proprietary Name:
Polymyxin B Sulfate And Trimethoprim Sulfate
Substance Name:
Polymyxin B Sulfate; Trimethoprim
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.
11-Digit NDC Billing Format:
70069031101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Somerset Therapeutics, Llc
Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s):
Ophthalmic - Administration to the external eye.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA211572
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-06-2024
Listing Expiration Date:
12-31-2025
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.

Frequently Asked Questions

What is NDC 70069-311-01?

The NDC Packaged Code 70069-311-01 is assigned to a 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 Somerset Therapeutics, Llc. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Is NDC 70069-311 included in the NDC Directory?

Yes, Polymyxin B Sulfate And Trimethoprim Sulfate with product code 70069-311 is active and included in the NDC Directory. The product was first marketed by Somerset Therapeutics, Llc on August 06, 2024 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 70069-311-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 70069-311-01?

The 11-digit format is 70069031101. 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
5-3-270069-311-015-4-270069-0311-01