sulfamethoxazole and trimethoprim (0615-8121)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler ncs healthcare of ky, llc dba vangard labs

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer

NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8121

Product ID 0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d

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)

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 06158121

Hyphenated Format 0615-8121

Supplemental Identifiers

RxCUI

198335

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 ANDA090624 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

800 mg/1
160 mg/1

source: ndc

Packaging

10 TABLET in 1 BLISTER PACK (0615-8121-10)
14 TABLET in 1 BLISTER PACK (0615-8121-14)
20 TABLET in 1 BLISTER PACK (0615-8121-20)
30 TABLET in 1 BLISTER PACK (0615-8121-39)

source: ndc

Packages (4)

0615-8121-10 10 TABLET in 1 BLISTER PACK (0615-8121-10) 0615-8121-14 14 TABLET in 1 BLISTER PACK (0615-8121-14) 0615-8121-20 20 TABLET in 1 BLISTER PACK (0615-8121-20) 0615-8121-39 30 TABLET in 1 BLISTER PACK (0615-8121-39)

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": "18da7fe1-4328-4868-9e5f-65e7d3dde75d", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198335"], "spl_set_id": ["c2307cc2-43ee-4319-ad58-d1d28a95e5aa"], "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": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BLISTER PACK (0615-8121-10)", "package_ndc": "0615-8121-10", "marketing_start_date": "20100216"}, {"sample": false, "description": "14 TABLET in 1 BLISTER PACK (0615-8121-14)", "package_ndc": "0615-8121-14", "marketing_start_date": "20100216"}, {"sample": false, "description": "20 TABLET in 1 BLISTER PACK (0615-8121-20)", "package_ndc": "0615-8121-20", "marketing_start_date": "20240130"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8121-39)", "package_ndc": "0615-8121-39", "marketing_start_date": "20240130"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d", "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": "0615-8121", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "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"}