Sulfatrim Suspension
NDC 50090-7836

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50090-7836?
  5. Sulfatrim Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Sulfatrim (sulfamethoxazole and trimethoprim) is a NDA-approved product labeled by A-s Medication Solutions. This medication is a combination of two antibiotics: sulfamethoxazole and trimethoprim. It is supplied as a red suspension for oral administration. This product entry covers the primary NDC 50090-7836 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50090-7836
Proprietary Name:
Sulfatrim
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:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Product Label ID:
80f7f00b-add4-4d6b-9e9c-bea29768c239
FDA Application Number: [6]
NDA018615
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-03-1983
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
RED (C48326)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 50090-7836?

The NDC code 50090-7836 is assigned by the FDA to the product Sulfatrim. It is commonly known by its generic name, sulfamethoxazole and trimethoprim. This pharmaceutical product is labeled by A-s Medication Solutions and is currently categorized as listed product. The medication is a suspension administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50090-7836-0. 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?

This medication is a combination of two antibiotics: sulfamethoxazole and trimethoprim. It is used to treat a wide variety of bacterial infections (such as middle ear, urine, respiratory, and intestinal infections). It is also used to prevent and treat a certain type of pneumonia (pneumocystis-type). This medication should not be used in children less than 2 months of age due to the risk of serious side effects. This medication treats only certain types of infections. It will not work for viral infections (such as flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

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 200 mg/5mL - 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 40 mg/5mL - 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: 208406 - SULFATRIM 200 MG / 40 MG in 5 mL Oral Suspension
  • RxCUI: 208406 - sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]
  • RxCUI: 208406 - SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]
  • RxCUI: 208406 - Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral Suspension
  • RxCUI: 313134 - sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral Suspension

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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".