Sulfamethoxazole And Trimethoprim Injection, Solution, Concentrate
NDC Package 0703-9514-83

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

Package Information

Sulfamethoxazole And Trimethoprim injection is contraindicated in the following situations: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 (5.4)]Documented megaloblastic anemia due to folate deficiency [see Warnings and Precautions (5.11)]Pediatric patients less than two months of age [see Use in Specific Populations (8.4)]Marked hepatic damage [see Warnings and Precautions (5.11, 5.14)]Severe renal insufficiency when renal function status cannot be monitored [see Warnings and Precautions (5.11, 5.14)]Concomitant administration with dofetilide2,3 [see Drug Interactions (7)]. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Teva Parenteral Medicines, Inc., this product is identified by NDC 0703-9514 and is authorized under FDA application ANDA073303.

Identification & Billing

NDC Package Code
0703-9514-83
Package Description
10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81)
Product Code
0703-9514
11-Digit Billing Format
00703951483
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 313137 - sulfamethoxazole 80 MG / trimethoprim 16 MG in 1 ML Injectable Solution
  • RxCUI: 313137 - sulfamethoxazole 80 MG/ML / trimethoprim 16 MG/ML Injectable Solution
  • RxCUI: 313137 - SMX 80 MG/ML / TMP 16 MG/ML Injectable Solution
  • RxCUI: 313137 - sulfamethoxazole 80 MG / trimethoprim 16 MG per 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.
  • Intravenous - Administration within or into a vein or veins.
  • 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 situations: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 (5.4)]Documented megaloblastic anemia due to folate deficiency [see Warnings and Precautions (5.11)]Pediatric patients less than two months of age [see Use in Specific Populations (8.4)]Marked hepatic damage [see Warnings and Precautions (5.11, 5.14)]Severe renal insufficiency when renal function status cannot be monitored [see Warnings and Precautions (5.11, 5.14)]Concomitant administration with dofetilide2,3 [see Drug Interactions (7)]

Regulatory & Marketing

Labeler Name
Teva Parenteral Medicines, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA073303
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-11-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0703-9514). Click a package code to view its specific billing and regulatory data.

0703-9514-03
10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01)
0703-9514-93
10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91)

* 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 0703-9514-83 identifies a specific commercial package of 10 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose (0703-9514-81) of Sulfamethoxazole And Trimethoprim, a human prescription drug labeled by Teva Parenteral Medicines, Inc.. 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 Teva Parenteral Medicines, Inc. on July 11, 2024. The current certification is valid through December 31, 2026.

How is this Teva Parenteral Medicines, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00703951483. 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)
0703-9514-83
11-Digit CMS (5-4-2)
00703-9514-83

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