sulfamethoxazole and trimethoprim (81033-012)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler kesin pharma

Dosage Form SUSPENSION

Routes

ORAL

Active Ingredients

sulfamethoxazole 200 mg/5mL, trimethoprim 40 mg/5mL

Manufacturer

Kesin Pharma

Identifiers & Regulatory

Product NDC 81033-012

Product ID 81033-012_35063fad-e644-2b68-e063-6394a90aedc8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA077612

Listing Expiration 2026-12-31

Marketing Start 2022-07-05

Pharmacologic Class

Established (EPC)

sulfonamide antimicrobial [epc] dihydrofolate reductase inhibitor antibacterial [epc]

Mechanism of Action

cytochrome p450 2c9 inhibitors [moa] dihydrofolate reductase inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] organic cation transporter 2 inhibitors [moa]

Chemical Structure

sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81033012

Hyphenated Format 81033-012

Supplemental Identifiers

RxCUI

313134

UNII

JE42381TNV AN164J8Y0X

NUI

N0000175504 M0020790 N0000185504 N0000175489 N0000000191 N0000187062 N0000187061

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 ANDA077612 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

200 mg/5mL
40 mg/5mL

source: ndc

Packaging

40 CUP, UNIT-DOSE in 1 CARTON (81033-012-40) / 20 mL in 1 CUP, UNIT-DOSE (81033-012-20)

source: ndc

Packages (1)

81033-012-40 40 CUP, UNIT-DOSE in 1 CARTON (81033-012-40) / 20 mL in 1 CUP, UNIT-DOSE (81033-012-20)

Ingredients (2)

sulfamethoxazole (200 mg/5mL) trimethoprim (40 mg/5mL)

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": "35063fad-e644-2b68-e063-6394a90aedc8", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["313134"], "spl_set_id": ["31f9e720-3869-061f-e063-6294a90a43b4"], "pharm_class_cs": ["Sulfonamides [CS]"], "pharm_class_epc": ["Sulfonamide Antimicrobial [EPC]", "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C9 Inhibitors [MoA]", "Dihydrofolate Reductase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Kesin Pharma"]}, "finished": true, "packaging": [{"sample": false, "description": "40 CUP, UNIT-DOSE in 1 CARTON (81033-012-40)  / 20 mL in 1 CUP, UNIT-DOSE (81033-012-20)", "package_ndc": "81033-012-40", "marketing_start_date": "20250404"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "81033-012_35063fad-e644-2b68-e063-6394a90aedc8", "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": "81033-012", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Kesin Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethoxazole and Trimethoprim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "200 mg/5mL"}, {"name": "TRIMETHOPRIM", "strength": "40 mg/5mL"}], "application_number": "ANDA077612", "marketing_category": "ANDA", "marketing_start_date": "20220705", "listing_expiration_date": "20261231"}