sulfatrim

Generic: sulfamethoxazole and trimethoprim

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfatrim
Generic Name sulfamethoxazole and trimethoprim
Labeler pai holdings, llc dba pai pharma
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

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

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0854
Product ID 0121-0854_a13ce54e-96e8-437a-b4f7-0af852a5a10a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018615
Listing Expiration 2026-12-31
Marketing Start 1983-07-03

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 01210854
Hyphenated Format 0121-0854

Supplemental Identifiers

RxCUI
208406 313134
UNII
JE42381TNV AN164J8Y0X
NUI
N0000175504 M0020790 N0000185504 N0000175489 N0000000191 N0000187062 N0000187061

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 sulfatrim (source: ndc)
Generic Name sulfamethoxazole and trimethoprim (source: ndc)
Application Number NDA018615 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
  • 40 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0121-0854-16)
source: ndc

Packages (1)

0121-0854-16 473 mL in 1 BOTTLE (0121-0854-16)

Ingredients (2)

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

Linked Drug Pages (1)

SULFATRIM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a13ce54e-96e8-437a-b4f7-0af852a5a10a", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["208406", "313134"], "spl_set_id": ["c62086ea-ba15-40f5-8431-4639c60c9825"], "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": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0121-0854-16)", "package_ndc": "0121-0854-16", "marketing_start_date": "19830703"}], "brand_name": "SULFATRIM", "product_id": "0121-0854_a13ce54e-96e8-437a-b4f7-0af852a5a10a", "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": "0121-0854", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SULFATRIM", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "200 mg/5mL"}, {"name": "TRIMETHOPRIM", "strength": "40 mg/5mL"}], "application_number": "NDA018615", "marketing_category": "NDA", "marketing_start_date": "19830703", "listing_expiration_date": "20261231"}