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  5. NDC Package Code: 54348-625-14 Sulfamethox-tmp Ds

NDC Package 54348-625-14 Sulfamethox-tmp Ds

Sulfamethoxazole,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:
54348-625-14
Package Description:
1 BOTTLE in 1 BOX / 14 TABLET in 1 BOTTLE
Product Code:
54348-625
Proprietary Name:
Sulfamethox-tmp Ds
Non-Proprietary Name:
Sulfamethoxazole, 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 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 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 Streptococcus 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 tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are 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 a physician deems that sulfamethoxazole and trimethoprim could offer 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 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 Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.
11-Digit NDC Billing Format:
54348062514
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:
    Pharmpak, 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 800 mg/1
  • TRIMETHOPRIM 160 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:
    ANDA076899
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-11-2019
    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
    54348-625-061 BOTTLE in 1 BOX / 6 TABLET in 1 BOTTLE
    54348-625-101 BOTTLE in 1 BOX / 10 TABLET in 1 BOTTLE
    54348-625-201 BOTTLE in 1 BOX / 20 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54348-625-14?

    The NDC Packaged Code 54348-625-14 is assigned to a package of 1 bottle in 1 box / 14 tablet in 1 bottle of Sulfamethox-tmp Ds, a human prescription drug labeled by Pharmpak, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 54348-625 included in the NDC Directory?

    Yes, Sulfamethox-tmp Ds with product code 54348-625 is active and included in the NDC Directory. The product was first marketed by Pharmpak, Inc. on July 11, 2019 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 11-digit format for NDC 54348-625-14?

    The 11-digit format is 54348062514. 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
    5-3-254348-625-145-4-254348-0625-14