sulfamethoxazole and trimethoprim (53489-146)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler sun pharmaceutical industries, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer

Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 53489-146

Product ID 53489-146_31dd7abe-e7f2-10df-e063-6394a90a93e2

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA071017

Listing Expiration 2026-12-31

Marketing Start 1986-08-25

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 53489146

Hyphenated Format 53489-146

Supplemental Identifiers

RxCUI

198334 198335

UPC

0353489146012 0353489145015

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 ANDA071017 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

800 mg/1
160 mg/1

source: ndc

Packaging

100 TABLET in 1 BOTTLE, PLASTIC (53489-146-01)
500 TABLET in 1 BOTTLE, PLASTIC (53489-146-05)

source: ndc

Packages (2)

53489-146-01 100 TABLET in 1 BOTTLE, PLASTIC (53489-146-01) 53489-146-05 500 TABLET in 1 BOTTLE, PLASTIC (53489-146-05)

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": "31dd7abe-e7f2-10df-e063-6394a90a93e2", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "upc": ["0353489146012", "0353489145015"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["198334", "198335"], "spl_set_id": ["4833319a-a7b3-4bf4-bec4-6531b43182d4"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (53489-146-01)", "package_ndc": "53489-146-01", "marketing_start_date": "19860825"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (53489-146-05)", "package_ndc": "53489-146-05", "marketing_start_date": "19860825"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "53489-146_31dd7abe-e7f2-10df-e063-6394a90a93e2", "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": "53489-146", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "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": "ANDA071017", "marketing_category": "ANDA", "marketing_start_date": "19860825", "listing_expiration_date": "20261231"}