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  5. NDC Package Code: 70518-3206-0 Polymyxin B Sulfate And Trimethoprim Sulfate

NDC Package 70518-3206-0 Polymyxin B Sulfate And Trimethoprim Sulfate

Polymyxin B Sulfate,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:
70518-3206-0
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code:
70518-3206
Proprietary Name:
Polymyxin B Sulfate And Trimethoprim Sulfate
Non-Proprietary Name:
Polymyxin B Sulfate, Trimethoprim Sulfate
Substance Name:
Polymyxin B Sulfate; Trimethoprim Sulfate
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:
70518320600
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:
    Remedyrepack Inc.
    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):
  • POLYMYXIN B SULFATE 10000 [USP'U]/mL
  • TRIMETHOPRIM SULFATE 1 mg/mL
    • Pharmacologic Class(es):
  • Cytochrome P450 2C8 Inhibitors - [MoA] (Mechanism of Action)
  • Dihydrofolate Reductase Inhibitor Antibacterial - [EPC] (Established Pharmacologic Class)
  • Dihydrofolate Reductase Inhibitors - [MoA] (Mechanism of Action)
  • Organic Cation Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
  • Polymyxin-class Antibacterial - [EPC] (Established Pharmacologic Class)
  • Polymyxins - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA050567
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    08-30-2021
    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 70518-3206-0?

    The NDC Packaged Code 70518-3206-0 is assigned to a package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Polymyxin B Sulfate And Trimethoprim Sulfate, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 70518-3206 included in the NDC Directory?

    Yes, Polymyxin B Sulfate And Trimethoprim Sulfate with product code 70518-3206 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on August 30, 2021 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 11-digit format for NDC 70518-3206-0?

    The 11-digit format is 70518320600. 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 5-4-1 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
    5-4-170518-3206-05-4-270518-3206-00