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  5. NDC Package Code: 61971-115-05 Sulfamethoxazole And Trimethoprim

NDC Package 61971-115-05 Sulfamethoxazole And Trimethoprim

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
61971-115-05
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
61971-115
Proprietary Name:
Sulfamethoxazole And Trimethoprim
Non-Proprietary Name:
Sulfamethoxazole And Trimethoprim
Substance Name:
Sulfamethoxazole; Trimethoprim
Usage Information:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteriaR. 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 the empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent.Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis Carinii Pneumonia: For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.
11-Digit NDC Billing Format:
61971011505
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
500 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 198334 - sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet
  • RxCUI: 198334 - SMX 400 MG / TMP 80 MG Oral Tablet
  • RxCUI: 198335 - sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet
  • RxCUI: 198335 - SMX 800 MG / TMP 160 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Vista Pharmaceuticals, Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SULFAMETHOXAZOLE 400 mg/1
  • TRIMETHOPRIM 80 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 2C8 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inhibitors - [MoA] (Mechanism of Action)
  • Dihydrofolate Reductase Inhibitor Antibacterial - [EPC] (Established Pharmacologic Class)
  • Dihydrofolate Reductase Inhibitors - [MoA] (Mechanism of Action)
  • Organic Cation Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
  • Sulfonamide Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Sulfonamides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA076817
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-06-2006
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61971-115-01100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61971-115-05?

    The NDC Packaged Code 61971-115-05 is assigned to a package of 500 tablet in 1 bottle of Sulfamethoxazole And Trimethoprim, a human prescription drug labeled by Vista Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 61971-115 included in the NDC Directory?

    Yes, Sulfamethoxazole And Trimethoprim with product code 61971-115 is active and included in the NDC Directory. The product was first marketed by Vista Pharmaceuticals, Inc. on June 06, 2006 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 61971-115-05?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 500.

    What is the 11-digit format for NDC 61971-115-05?

    The 11-digit format is 61971011505. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-261971-115-055-4-261971-0115-05