sulfamethoxazole and trimethoprim (50268-728)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler avpak

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sulfamethoxazole 400 mg/1, trimethoprim 80 mg/1

Manufacturer

AvPAK

Identifiers & Regulatory

Product NDC 50268-728

Product ID 50268-728_423e8470-9b4e-1be3-e063-6294a90ad316

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090624

Listing Expiration 2026-12-31

Marketing Start 2014-09-23

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 50268728

Hyphenated Format 50268-728

Supplemental Identifiers

RxCUI

198334 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

400 mg/1
80 mg/1

source: ndc

Packaging

50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)

source: ndc

Packages (1)

50268-728-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11)

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": "423e8470-9b4e-1be3-e063-6294a90ad316", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198334", "198335"], "spl_set_id": ["29df8839-3dfa-0b2b-c5a3-906db6997b3b"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15)  / 1 TABLET in 1 BLISTER PACK (50268-728-11)", "package_ndc": "50268-728-15", "marketing_start_date": "20140923"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "50268-728_423e8470-9b4e-1be3-e063-6294a90ad316", "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": "50268-728", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "AvPAK", "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": "ANDA090624", "marketing_category": "ANDA", "marketing_start_date": "20140923", "listing_expiration_date": "20261231"}