sulfamethoxazole and trimethoprim

Generic: sulfamethoxazole and trimethoprim

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim
Generic Name sulfamethoxazole and trimethoprim
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfamethoxazole 400 mg/1, trimethoprim 80 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-271
Product ID 65162-271_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076899
Listing Expiration 2026-12-31
Marketing Start 2010-02-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162271
Hyphenated Format 65162-271

Supplemental Identifiers

RxCUI
198334 198335
UPC
0365162271102 0365162272109
UNII
AN164J8Y0X JE42381TNV
NUI
N0000175489 N0000000191 N0000187062 N0000187061 N0000175504 M0020790 N0000185504

Packaging Origin

Original Packager
true

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 ANDA076899 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (65162-271-05)
  • 100 TABLET in 1 BOTTLE (65162-271-10)
  • 1000 TABLET in 1 BOTTLE (65162-271-11)
  • 500 TABLET in 1 BOTTLE (65162-271-50)
source: ndc

Packages (4)

65162-271-05 50 TABLET in 1 BOTTLE (65162-271-05) 65162-271-10 100 TABLET in 1 BOTTLE (65162-271-10) 65162-271-11 1000 TABLET in 1 BOTTLE (65162-271-11) 65162-271-50 500 TABLET in 1 BOTTLE (65162-271-50)

Ingredients (2)

sulfamethoxazole (400 mg/1) trimethoprim (80 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": "6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "upc": ["0365162271102", "0365162272109"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["198334", "198335"], "spl_set_id": ["f0e73842-6002-43c2-97fc-0cadc1bf6346"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Dihydrofolate Reductase Inhibitor Antibacterial [EPC]", "Sulfonamide Antimicrobial [EPC]"], "pharm_class_moa": ["Dihydrofolate Reductase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (65162-271-05)", "package_ndc": "65162-271-05", "marketing_start_date": "20100225"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (65162-271-10)", "package_ndc": "65162-271-10", "marketing_start_date": "20100225"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-271-11)", "package_ndc": "65162-271-11", "marketing_start_date": "20100225"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65162-271-50)", "package_ndc": "65162-271-50", "marketing_start_date": "20100225"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "65162-271_6cbe0ea0-5ed0-4941-ad3c-4396a56fdfc6", "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": "65162-271", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethoxazole and Trimethoprim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "400 mg/1"}, {"name": "TRIMETHOPRIM", "strength": "80 mg/1"}], "application_number": "ANDA076899", "marketing_category": "ANDA", "marketing_start_date": "20100225", "listing_expiration_date": "20261231"}