sulfamethoxazole and trimethoprim

Generic: sulfamethoxazole and trimethoprim

Labeler: asclemed usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim
Generic Name sulfamethoxazole and trimethoprim
Labeler asclemed usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer
ASCLEMED USA INC.

Identifiers & Regulatory

Product NDC 76420-405
Product ID 76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7
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 76420405
Hyphenated Format 76420-405

Supplemental Identifiers

RxCUI
198335
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
  • 100 TABLET in 1 BOTTLE (76420-405-01)
  • 500 TABLET in 1 BOTTLE (76420-405-05)
  • 6 TABLET in 1 BOTTLE (76420-405-06)
  • 10 TABLET in 1 BOTTLE (76420-405-10)
  • 14 TABLET in 1 BOTTLE (76420-405-14)
  • 20 TABLET in 1 BOTTLE (76420-405-20)
  • 28 TABLET in 1 BOTTLE (76420-405-28)
  • 30 TABLET in 1 BOTTLE (76420-405-30)
source: ndc

Packages (8)

76420-405-01 100 TABLET in 1 BOTTLE (76420-405-01) 76420-405-05 500 TABLET in 1 BOTTLE (76420-405-05) 76420-405-06 6 TABLET in 1 BOTTLE (76420-405-06) 76420-405-10 10 TABLET in 1 BOTTLE (76420-405-10) 76420-405-14 14 TABLET in 1 BOTTLE (76420-405-14) 76420-405-20 20 TABLET in 1 BOTTLE (76420-405-20) 76420-405-28 28 TABLET in 1 BOTTLE (76420-405-28) 76420-405-30 30 TABLET in 1 BOTTLE (76420-405-30)

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": "3810e86a-b46f-14d1-e063-6394a90a1ae7", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198335"], "spl_set_id": ["42abfb9e-5108-4642-abfb-45c985df588c"], "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": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-405-01)", "package_ndc": "76420-405-01", "marketing_start_date": "20250620"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (76420-405-05)", "package_ndc": "76420-405-05", "marketing_start_date": "20250620"}, {"sample": false, "description": "6 TABLET in 1 BOTTLE (76420-405-06)", "package_ndc": "76420-405-06", "marketing_start_date": "20250620"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (76420-405-10)", "package_ndc": "76420-405-10", "marketing_start_date": "20250620"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (76420-405-14)", "package_ndc": "76420-405-14", "marketing_start_date": "20250620"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (76420-405-20)", "package_ndc": "76420-405-20", "marketing_start_date": "20250620"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (76420-405-28)", "package_ndc": "76420-405-28", "marketing_start_date": "20250620"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-405-30)", "package_ndc": "76420-405-30", "marketing_start_date": "20250620"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "76420-405_3810e86a-b46f-14d1-e063-6394a90a1ae7", "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": "76420-405", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "ASCLEMED USA 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"}