sulfamethoxazole and trimethoprim (70069-361)

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim

Generic Name sulfamethoxazole and trimethoprim

Labeler somerset therapeutics, llc

Dosage Form INJECTION, SOLUTION, CONCENTRATE

Routes

INTRAVENOUS

Active Ingredients

sulfamethoxazole 80 mg/mL, trimethoprim 16 mg/mL

Manufacturer

Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-361

Product ID 70069-361_012dfac7-9b72-48a5-a364-e62bbe150cfe

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212231

Listing Expiration 2026-12-31

Marketing Start 2019-08-29

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 70069361

Hyphenated Format 70069-361

Supplemental Identifiers

RxCUI

313137 1809083

UPC

0370069362105 0370069363010 0370069362013 0370069361108 0370069361016

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 ANDA212231 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

80 mg/mL
16 mg/mL

source: ndc

Packaging

10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01)

source: ndc

Packages (1)

70069-361-10 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01)

Ingredients (2)

sulfamethoxazole (80 mg/mL) trimethoprim (16 mg/mL)

Linked Drug Pages (1)

Sulfamethoxazole and Trimethoprim ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "012dfac7-9b72-48a5-a364-e62bbe150cfe", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "upc": ["0370069362105", "0370069363010", "0370069362013", "0370069361108", "0370069361016"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["313137", "1809083"], "spl_set_id": ["ebb570bb-6e5e-489e-875c-9e7b3a6d716a"], "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": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70069-361-10)  / 5 mL in 1 VIAL (70069-361-01)", "package_ndc": "70069-361-10", "marketing_start_date": "20190829"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "70069-361_012dfac7-9b72-48a5-a364-e62bbe150cfe", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "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": "70069-361", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethoxazole and Trimethoprim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "80 mg/mL"}, {"name": "TRIMETHOPRIM", "strength": "16 mg/mL"}], "application_number": "ANDA212231", "marketing_category": "ANDA", "marketing_start_date": "20190829", "listing_expiration_date": "20261231"}