Trimethoprim Sulfate And Polymyxin B Sulfate Solution
NDC Package 63187-193-10
Package Information
Trimethoprim Sulfate And Polymyxin B Sulfate solution is trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution 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 influenza and Pseudomonas aeruginosa.* *Efficacy for this organism in this organ system was studied in fewer than 10 infections. This formulation utilizes a solution delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 63187-193 and is authorized under FDA application ANDA065006.
Identification & Billing
- 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
- 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]
Regulatory & Marketing
Hierarchy Structure
- 63187 - Proficient Rx Lp
- 63187-193 - Trimethoprim Sulfate And Polymyxin B Sulfate
- 63187-193-10 - 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
- 63187-193 - Trimethoprim Sulfate And Polymyxin B Sulfate
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 63187-193-10 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Trimethoprim Sulfate And Polymyxin B Sulfate, a human prescription drug labeled by Proficient Rx Lp. This solution is formulated for ophthalmic use and contains polymyxin b sulfate; trimethoprim 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 Proficient Rx Lp on December 17, 1998. The current certification is valid through December 31, 2026.
How is this Proficient Rx Lp product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 63187019310. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.