Sulfamethoxazole And Trimethoprim Suspension
NDC Package 0121-0853-20

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

Package Information

Sulfamethoxazole And Trimethoprim suspension is to reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a suspension delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0853 and is authorized under FDA application NDA018615.

Identification & Billing

NDC Package Code
0121-0853-20
Package Description
10 CUP, UNIT-DOSE in 1 TRAY / 20 mL in 1 CUP, UNIT-DOSE
Product Code
0121-0853
11-Digit Billing Format
00121085320
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313134 - sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral Suspension
  • RxCUI: 313134 - sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension
  • RxCUI: 313134 - SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension
  • RxCUI: 313134 - sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension
  • RxCUI: 313134 - sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension

Clinical Specifications

Proprietary Name
Sulfamethoxazole And Trimethoprim
Non-Proprietary Name
Sulfamethoxazole And Trimethoprim
Substance Name
Sulfamethoxazole; Trimethoprim
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Prescription Drug
FDA Application #
NDA018615
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-05-2024
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 0121-0853-20 identifies a specific commercial package of 10 cup, unit-dose in 1 tray / 20 ml in 1 cup, unit-dose of Sulfamethoxazole And Trimethoprim, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. This suspension is formulated for oral use and contains sulfamethoxazole; 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 Pai Holdings, Llc Dba Pai Pharma on August 05, 2024. The current certification is valid through December 31, 2026.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121085320. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0121-0853-20
11-Digit CMS (5-4-2)
00121-0853-20

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