sulfamethoxazole and trimethoprim (69043-010)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler cronus pharma llc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sulfamethoxazole 400 mg/1, trimethoprim 80 mg/1

Manufacturer

Cronus Pharma LLC

Identifiers & Regulatory

Product NDC 69043-010

Product ID 69043-010_17de019d-ffdf-436a-bcae-2941f844123a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090624

Listing Expiration 2026-12-31

Marketing Start 2010-02-16

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 69043010

Hyphenated Format 69043-010

Supplemental Identifiers

RxCUI

198334 198335

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 ANDA090624 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

400 mg/1
80 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (69043-010-01)
500 TABLET in 1 BOTTLE (69043-010-05)

source: ndc

Packages (2)

69043-010-01 100 TABLET in 1 BOTTLE (69043-010-01) 69043-010-05 500 TABLET in 1 BOTTLE (69043-010-05)

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": "17de019d-ffdf-436a-bcae-2941f844123a", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["198334", "198335"], "spl_set_id": ["1b5de94f-973a-4b5a-91d7-45e05be78650"], "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": ["Cronus Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69043-010-01)", "package_ndc": "69043-010-01", "marketing_start_date": "20100216"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69043-010-05)", "package_ndc": "69043-010-05", "marketing_start_date": "20100216"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "69043-010_17de019d-ffdf-436a-bcae-2941f844123a", "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": "69043-010", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Cronus Pharma 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": "ANDA090624", "marketing_category": "ANDA", "marketing_start_date": "20100216", "listing_expiration_date": "20261231"}