sulfamethoxazole and trimethoprim

Generic: sulfamethoxazole and trimethoprim

Labeler: vista 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 vista pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfamethoxazole 400 mg/1, trimethoprim 80 mg/1

Manufacturer
Vista Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 61971-115
Product ID 61971-115_69d5e1fe-d9e9-4afa-bd62-8df032a34d32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076817
Listing Expiration 2026-12-31
Marketing Start 2006-06-06

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 61971115
Hyphenated Format 61971-115

Supplemental Identifiers

RxCUI
198334 198335
UPC
0361971115019 0361971115057 0361971120013 0361971120051
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 ANDA076817 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (61971-115-01)
  • 500 TABLET in 1 BOTTLE (61971-115-05)
source: ndc

Packages (2)

61971-115-01 100 TABLET in 1 BOTTLE (61971-115-01) 61971-115-05 500 TABLET in 1 BOTTLE (61971-115-05)

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": "69d5e1fe-d9e9-4afa-bd62-8df032a34d32", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "upc": ["0361971115019", "0361971115057", "0361971120013", "0361971120051"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["198334", "198335"], "spl_set_id": ["3edca473-8fdc-462a-b378-6c3279503a70"], "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": ["Vista Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (61971-115-01)", "package_ndc": "61971-115-01", "marketing_start_date": "20060606"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (61971-115-05)", "package_ndc": "61971-115-05", "marketing_start_date": "20060606"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "61971-115_69d5e1fe-d9e9-4afa-bd62-8df032a34d32", "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": "61971-115", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Vista Pharmaceuticals, Inc.", "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": "ANDA076817", "marketing_category": "ANDA", "marketing_start_date": "20060606", "listing_expiration_date": "20261231"}