sulfamethoxazole and trimethoprim (62135-873)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler chartwell rx, llc

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

sulfamethoxazole 800 mg/20mL, trimethoprim 160 mg/20mL

Manufacturer

Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-873

Product ID 62135-873_316d17d0-4fb7-a200-e063-6394a90aa5e2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA077785

Listing Expiration 2026-12-31

Marketing Start 2007-01-24

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 62135873

Hyphenated Format 62135-873

Supplemental Identifiers

RxCUI

313134

UPC

0362135749477

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 ANDA077785 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

800 mg/20mL
160 mg/20mL

source: ndc

Packaging

2 TRAY in 1 BOX (62135-873-24) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-873-52)

source: ndc

Packages (1)

62135-873-24 2 TRAY in 1 BOX (62135-873-24) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-873-52)

Ingredients (2)

sulfamethoxazole (800 mg/20mL) trimethoprim (160 mg/20mL)

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": "316d17d0-4fb7-a200-e063-6394a90aa5e2", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "upc": ["0362135749477"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["313134"], "spl_set_id": ["b5b7aba5-f93d-46bc-a3c2-712de1c5cff3"], "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": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-873-24)  / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-873-52)", "package_ndc": "62135-873-24", "marketing_start_date": "20240530"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "62135-873_316d17d0-4fb7-a200-e063-6394a90aa5e2", "dosage_form": "SUSPENSION", "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": "62135-873", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethoxazole and Trimethoprim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "800 mg/20mL"}, {"name": "TRIMETHOPRIM", "strength": "160 mg/20mL"}], "application_number": "ANDA077785", "marketing_category": "ANDA", "marketing_start_date": "20070124", "listing_expiration_date": "20261231"}