sulfamethoxazole and trimethoprim

Generic: sulfamethoxazole and trimethoprim

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim
Generic Name sulfamethoxazole and trimethoprim
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-018
Product ID 72789-018_3143fb81-1052-c193-e063-6394a90a18e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090624
Listing Expiration 2026-12-31
Marketing Start 2010-02-16

Pharmacologic Class

Established (EPC)
sulfonamide antimicrobial [epc] dihydrofolate reductase inhibitor antibacterial [epc]
Mechanism of Action
cytochrome p450 2c9 inhibitors [moa] dihydrofolate reductase inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] organic cation transporter 2 inhibitors [moa]
Chemical Structure
sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789018
Hyphenated Format 72789-018

Supplemental Identifiers

RxCUI
198335
UPC
0372789018065
UNII
JE42381TNV AN164J8Y0X
NUI
N0000175504 M0020790 N0000185504 N0000175489 N0000000191 N0000187062 N0000187061

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sulfamethoxazole and trimethoprim (source: ndc)
Generic Name sulfamethoxazole and trimethoprim (source: ndc)
Application Number ANDA090624 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 2 TABLET in 1 BOTTLE, PLASTIC (72789-018-02)
  • 4 TABLET in 1 BOTTLE, PLASTIC (72789-018-04)
  • 6 TABLET in 1 BOTTLE, PLASTIC (72789-018-06)
  • 10 TABLET in 1 BOTTLE, PLASTIC (72789-018-10)
  • 14 TABLET in 1 BOTTLE, PLASTIC (72789-018-14)
  • 20 TABLET in 1 BOTTLE, PLASTIC (72789-018-20)
  • 28 TABLET in 1 BOTTLE, PLASTIC (72789-018-28)
  • 40 TABLET in 1 BOTTLE, PLASTIC (72789-018-40)
  • 60 TABLET in 1 BOTTLE, PLASTIC (72789-018-60)
source: ndc

Packages (9)

72789-018-02 2 TABLET in 1 BOTTLE, PLASTIC (72789-018-02) 72789-018-04 4 TABLET in 1 BOTTLE, PLASTIC (72789-018-04) 72789-018-06 6 TABLET in 1 BOTTLE, PLASTIC (72789-018-06) 72789-018-10 10 TABLET in 1 BOTTLE, PLASTIC (72789-018-10) 72789-018-14 14 TABLET in 1 BOTTLE, PLASTIC (72789-018-14) 72789-018-20 20 TABLET in 1 BOTTLE, PLASTIC (72789-018-20) 72789-018-28 28 TABLET in 1 BOTTLE, PLASTIC (72789-018-28) 72789-018-40 40 TABLET in 1 BOTTLE, PLASTIC (72789-018-40) 72789-018-60 60 TABLET in 1 BOTTLE, PLASTIC (72789-018-60)

Ingredients (2)

sulfamethoxazole (800 mg/1) trimethoprim (160 mg/1)

Linked Drug Pages (1)

Sulfamethoxazole and Trimethoprim ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3143fb81-1052-c193-e063-6394a90a18e8", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "upc": ["0372789018065"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198335"], "spl_set_id": ["3ef62512-0dc3-4821-9b60-6b375841c4c0"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Sulfonamide Antimicrobial [EPC]", "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET in 1 BOTTLE, PLASTIC (72789-018-02)", "package_ndc": "72789-018-02", "marketing_start_date": "20200410"}, {"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (72789-018-04)", "package_ndc": "72789-018-04", "marketing_start_date": "20200226"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (72789-018-06)", "package_ndc": "72789-018-06", "marketing_start_date": "20191017"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (72789-018-10)", "package_ndc": "72789-018-10", "marketing_start_date": "20191029"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE, PLASTIC (72789-018-14)", "package_ndc": "72789-018-14", "marketing_start_date": "20191101"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (72789-018-20)", "package_ndc": "72789-018-20", "marketing_start_date": "20191017"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (72789-018-28)", "package_ndc": "72789-018-28", "marketing_start_date": "20200213"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE, PLASTIC (72789-018-40)", "package_ndc": "72789-018-40", "marketing_start_date": "20191122"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (72789-018-60)", "package_ndc": "72789-018-60", "marketing_start_date": "20191017"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "72789-018_3143fb81-1052-c193-e063-6394a90a18e8", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]", "Dihydrofolate Reductase Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "Sulfonamide Antimicrobial [EPC]", "Sulfonamides [CS]"], "product_ndc": "72789-018", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethoxazole and Trimethoprim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "800 mg/1"}, {"name": "TRIMETHOPRIM", "strength": "160 mg/1"}], "application_number": "ANDA090624", "marketing_category": "ANDA", "marketing_start_date": "20100216", "listing_expiration_date": "20261231"}