sulfamethoxazole and trimethoprim (82868-092)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler northwind health company, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer

Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-092

Product ID 82868-092_471c5440-be67-e1de-e063-6394a90ad8c7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090624

Listing Expiration 2026-12-31

Marketing Start 2025-11-06

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 82868092

Hyphenated Format 82868-092

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

28 TABLET in 1 BOTTLE, PLASTIC (82868-092-28)

source: ndc

Packages (1)

82868-092-28 28 TABLET in 1 BOTTLE, PLASTIC (82868-092-28)

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": "471c5440-be67-e1de-e063-6394a90ad8c7", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198335"], "spl_set_id": ["471c5995-a4df-fbe3-e063-6394a90aa50e"], "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": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (82868-092-28)", "package_ndc": "82868-092-28", "marketing_start_date": "20251106"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "82868-092_471c5440-be67-e1de-e063-6394a90ad8c7", "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": "82868-092", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Northwind Health Company, LLC", "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": "20251106", "listing_expiration_date": "20261231"}