sulfamethoxazole and trimethoprim (70518-3454)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler remedyrepack inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

sulfamethoxazole 400 mg/1, trimethoprim 80 mg/1

Manufacturer

REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3454

Product ID 70518-3454_3bb7008b-1feb-6ee9-e063-6294a90a7d93

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090624

Listing Expiration 2026-12-31

Marketing Start 2022-07-18

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 705183454

Hyphenated Format 70518-3454

Supplemental Identifiers

RxCUI

198334

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

400 mg/1
80 mg/1

source: ndc

Packaging

6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)
20 TABLET in 1 BOTTLE, PLASTIC (70518-3454-3)
10 TABLET in 1 BOTTLE, PLASTIC (70518-3454-4)

source: ndc

Packages (3)

70518-3454-2 6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2) 70518-3454-3 20 TABLET in 1 BOTTLE, PLASTIC (70518-3454-3) 70518-3454-4 10 TABLET in 1 BOTTLE, PLASTIC (70518-3454-4)

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": "3bb7008b-1feb-6ee9-e063-6294a90a7d93", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198334"], "spl_set_id": ["ce44959b-4bfe-4ba9-9fc2-7f9d4663d542"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE, PLASTIC (70518-3454-2)", "package_ndc": "70518-3454-2", "marketing_start_date": "20240726"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (70518-3454-3)", "package_ndc": "70518-3454-3", "marketing_start_date": "20250701"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (70518-3454-4)", "package_ndc": "70518-3454-4", "marketing_start_date": "20250806"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "70518-3454_3bb7008b-1feb-6ee9-e063-6294a90a7d93", "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": "70518-3454", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "REMEDYREPACK INC.", "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": "20220718", "listing_expiration_date": "20261231"}