sulfamethoxazole and trimethoprim (62135-897)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler chartwell rx, llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sulfamethoxazole 400 mg/1, trimethoprim 80 mg/1

Manufacturer

Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-897

Product ID 62135-897_10445eb8-e525-d945-e063-6294a90ae0f2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078060

Listing Expiration 2026-12-31

Marketing Start 2007-01-25

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 62135897

Hyphenated Format 62135-897

Supplemental Identifiers

RxCUI

198334 198335

UPC

0362135897185 0362135898182 0362135898908 0362135897901

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 ANDA078060 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

400 mg/1
80 mg/1

source: ndc

Packaging

180 TABLET in 1 BOTTLE (62135-897-18)
90 TABLET in 1 BOTTLE (62135-897-90)

source: ndc

Packages (2)

62135-897-18 180 TABLET in 1 BOTTLE (62135-897-18) 62135-897-90 90 TABLET in 1 BOTTLE (62135-897-90)

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": "10445eb8-e525-d945-e063-6294a90ae0f2", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "upc": ["0362135897185", "0362135898182", "0362135898908", "0362135897901"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["198334", "198335"], "spl_set_id": ["e4a7572f-b372-40eb-963f-919ac100b7a8"], "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": "180 TABLET in 1 BOTTLE (62135-897-18)", "package_ndc": "62135-897-18", "marketing_start_date": "20240111"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-897-90)", "package_ndc": "62135-897-90", "marketing_start_date": "20240111"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "62135-897_10445eb8-e525-d945-e063-6294a90ae0f2", "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": "62135-897", "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": "400 mg/1"}, {"name": "TRIMETHOPRIM", "strength": "80 mg/1"}], "application_number": "ANDA078060", "marketing_category": "ANDA", "marketing_start_date": "20070125", "listing_expiration_date": "20261231"}