sulfamethoxazole and trimethoprim (65862-420)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler aurobindo pharma limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-420

Product ID 65862-420_e4ea8e99-58d4-4c1b-b84c-db0838610059

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 65862420

Hyphenated Format 65862-420

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

800 mg/1
160 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE (65862-420-01)
500 TABLET in 1 BOTTLE (65862-420-05)
20 TABLET in 1 BOTTLE (65862-420-20)
1000 TABLET in 1 BOTTLE (65862-420-99)

source: ndc

Packages (4)

65862-420-01 100 TABLET in 1 BOTTLE (65862-420-01) 65862-420-05 500 TABLET in 1 BOTTLE (65862-420-05) 65862-420-20 20 TABLET in 1 BOTTLE (65862-420-20) 65862-420-99 1000 TABLET in 1 BOTTLE (65862-420-99)

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": "e4ea8e99-58d4-4c1b-b84c-db0838610059", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["198334", "198335"], "spl_set_id": ["284b5dac-2b8d-46bf-95fe-80ce03fa178a"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-420-01)", "package_ndc": "65862-420-01", "marketing_start_date": "20100216"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-420-05)", "package_ndc": "65862-420-05", "marketing_start_date": "20100216"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (65862-420-20)", "package_ndc": "65862-420-20", "marketing_start_date": "20100216"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-420-99)", "package_ndc": "65862-420-99", "marketing_start_date": "20100216"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "65862-420_e4ea8e99-58d4-4c1b-b84c-db0838610059", "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": "65862-420", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Aurobindo Pharma Limited", "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": "20100216", "listing_expiration_date": "20261231"}