NDC Package 61919-645-28 Sulfameth/trimeth-ds

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

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:
61919-645-28
Package Description:
28 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Sulfameth/trimeth-ds
Non-Proprietary Name:
Sulfameth/trimeth-ds
Substance Name:
Sulfamethoxazole; Trimethoprim
Usage Information:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 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 empiric selection of therapy.Urinary Tract InfectionsFor 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 MediaFor the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim tablets offer 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 tablets, USP in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets, USP are not indicated for prophylactic or prolonged administration in otitis media at any age.Acute Exacerbations of Chronic Bronchitis in AdultsFor the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim tablets, USP could offer some advantage over the use of a single antimicrobial agent.ShigellosisFor the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.Pneumocystis jiroveci Pneumonia For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P. jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia. Traveler's Diarrhea in AdultsFor the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
11-Digit NDC Billing Format:
61919064528
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
28 EA
NDC to RxNorm Crosswalk:
  • 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:
    Direct Rx
    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.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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:
    ANDA090624
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-11-2018
    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
    61919-645-022 TABLET in 1 BOTTLE
    61919-645-066 TABLET in 1 BOTTLE
    61919-645-1010 TABLET in 1 BOTTLE
    61919-645-1414 TABLET in 1 BOTTLE
    61919-645-2020 TABLET in 1 BOTTLE
    61919-645-3030 TABLET in 1 BOTTLE
    61919-645-5656 TABLET in 1 BOTTLE
    61919-645-6060 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61919-645-28?

    The NDC Packaged Code 61919-645-28 is assigned to a package of 28 tablet in 1 bottle of Sulfameth/trimeth-ds, a human prescription drug labeled by Direct Rx. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package.

    Is NDC 61919-645 included in the NDC Directory?

    Yes, Sulfameth/trimeth-ds with product code 61919-645 is active and included in the NDC Directory. The product was first marketed by Direct Rx on December 11, 2018 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 61919-645-28?

    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 28.

    What is the 11-digit format for NDC 61919-645-28?

    The 11-digit format is 61919064528. 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
    5-3-261919-645-285-4-261919-0645-28