Sulfamethoxazole And Trimethoprim Injection, Solution, Concentrate
NDC Package 70069-362-10

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

Package Information

Sulfamethoxazole And Trimethoprim injection is contraindicated in the following:Known hypersensitivity to trimethoprim or sulfonamides [see Warnings and Precautions (5.2)]History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides [see Warnings and Precautions (5.3)]Patients with documented megaloblastic anemia due to folate deficiency [see Warnings and Precautions (5.10)]Pediatric patients less than two months of age [see Use in Specific Populations (8.4)]Marked hepatic damage [see Warnings and Precautions (5.10, 5.13)]Severe renal insufficiency when renal function status cannot be monitored [see Warnings and Precautions (5.10, 5.13)]Concomitant administration with dofetilide2,3[see Drug Interactions (7)]. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Somerset Therapeutics, Llc, this product is identified by NDC 70069-362 and is authorized under FDA application ANDA212231.

Identification & Billing

NDC Package Code
70069-362-10
Package Description
10 VIAL in 1 CARTON / 10 mL in 1 VIAL (70069-362-01)
Product Code
70069-362
11-Digit Billing Format
70069036210
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1809083 - sulfamethoxazole 400 MG / trimethoprim 80 MG in 5 ML Injection
  • RxCUI: 1809083 - 5 ML sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injection
  • RxCUI: 1809083 - 5 ML SMX 80 MG/ML / TMP 16 MG/ML Injection
  • RxCUI: 1809083 - sulfamethoxazole 400 MG / trimethoprim 80 MG per 5 ML Injection
  • RxCUI: 313137 - sulfamethoxazole 80 MG / trimethoprim 16 MG in 1 ML Injectable Solution

Clinical Specifications

Proprietary Name
Sulfamethoxazole And Trimethoprim
Non-Proprietary Name
Sulfamethoxazole And Trimethoprim
Substance Name
Sulfamethoxazole; Trimethoprim
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Sulfamethoxazole and trimethoprim injection is contraindicated in the following:Known hypersensitivity to trimethoprim or sulfonamides [see Warnings and Precautions (5.2)]History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides [see Warnings and Precautions (5.3)]Patients with documented megaloblastic anemia due to folate deficiency [see Warnings and Precautions (5.10)]Pediatric patients less than two months of age [see Use in Specific Populations (8.4)]Marked hepatic damage [see Warnings and Precautions (5.10, 5.13)]Severe renal insufficiency when renal function status cannot be monitored [see Warnings and Precautions (5.10, 5.13)]Concomitant administration with dofetilide2,3[see Drug Interactions (7)]

Regulatory & Marketing

Labeler Name
Somerset Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212231
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-29-2019
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J2865
Source: PDAC
INJECTION, SULFAMETHOXAZOLE 5 MG AND TRIMETHOPRIM 1 MG
HCPCS Dosage 5 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 70069-362-10 identifies a specific commercial package of 10 vial in 1 carton / 10 ml in 1 vial (70069-362-01) of Sulfamethoxazole And Trimethoprim, a human prescription drug labeled by Somerset Therapeutics, Llc. This injection, solution, concentrate is formulated for intravenous 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 Somerset Therapeutics, Llc on August 29, 2019. The current certification is valid through December 31, 2026.

How is this Somerset Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70069036210. 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 (5-3-2)
70069-362-10
11-Digit CMS (5-4-2)
70069-0362-10

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