Sulfamethoxazole And Trimethoprim Injection, Solution, Concentrate
NDC 70069-363

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70069-363?
  5. Sulfamethoxazole And Trimethoprim Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Sulfamethoxazole And Trimethoprim is a ANDA-approved product labeled by Somerset Therapeutics, Llc. This medication is typically used as a cytochrome p450 2c8 inhibitors [moa]. It is supplied as a yellow injection, solution, concentrate for intravenous administration. This product entry covers the primary NDC 70069-363 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
70069-363
Proprietary Name:
Sulfamethoxazole And Trimethoprim
Non-Proprietary Name: [1]
Sulfamethoxazole And Trimethoprim
Substance Name: [2]
Sulfamethoxazole; Trimethoprim
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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(s): [4]
Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Somerset Therapeutics, Llc
Labeler Code:
70069
Product Label ID:
ebb570bb-6e5e-489e-875c-9e7b3a6d716a
FDA Application Number: [6]
ANDA212231
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
08-29-2019
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330 - CLEAR, COLORLESS TO PALE YELLOW SOLUTION)

Code Structure Chart

Product Details

What is NDC 70069-363?

The NDC code 70069-363 is assigned by the FDA to the product Sulfamethoxazole And Trimethoprim. This pharmaceutical product is labeled by Somerset Therapeutics, Llc and is currently categorized as listed product. The medication is a injection, solution, concentrate administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 70069-363-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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)]

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SULFAMETHOXAZOLE 80 mg/mL - A bacteriostatic antibacterial agent that interferes with folic acid synthesis in susceptible bacteria. Its broad spectrum of activity has been limited by the development of resistance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p208)
  • TRIMETHOPRIM 16 mg/mL - A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to PYRIMETHAMINE. It is potentiated by SULFONAMIDES and the TRIMETHOPRIM, SULFAMETHOXAZOLE DRUG COMBINATION is the form most often used. It is sometimes used alone as an antimalarial. TRIMETHOPRIM RESISTANCE has been reported.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the full disclaimer at the bottom of this page.

Patient Education

Co-trimoxazole Injection


Co-trimoxazole injection is used to treat certain infections that are caused by bacteria such as infection of the intestine, lungs (pneumonia), and urinary tract. Co-trimoxazole should not be used in children younger than 2 months of age. Co-trimoxazole injection is in a class of medications called sulfonamides. It works by killing bacteria. Antibiotics such as co-trimoxazole injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".