sulfamethox-tmp ds

Generic: sulfamethoxazole, trimethoprim

Labeler: pharmpak, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfamethox-tmp ds
Generic Name sulfamethoxazole, trimethoprim
Labeler pharmpak, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-625
Product ID 54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076899
Listing Expiration 2026-12-31
Marketing Start 2019-07-11

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 54348625
Hyphenated Format 54348-625

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 sulfamethox-tmp ds (source: ndc)
Generic Name sulfamethoxazole, trimethoprim (source: ndc)
Application Number ANDA076899 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-625-06) / 6 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-625-10) / 10 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-625-14) / 14 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-625-20) / 20 TABLET in 1 BOTTLE
source: ndc

Packages (4)

54348-625-06 1 BOTTLE in 1 BOX (54348-625-06) / 6 TABLET in 1 BOTTLE 54348-625-10 1 BOTTLE in 1 BOX (54348-625-10) / 10 TABLET in 1 BOTTLE 54348-625-14 1 BOTTLE in 1 BOX (54348-625-14) / 14 TABLET in 1 BOTTLE 54348-625-20 1 BOTTLE in 1 BOX (54348-625-20) / 20 TABLET in 1 BOTTLE

Ingredients (2)

sulfamethoxazole (800 mg/1) trimethoprim (160 mg/1)

Linked Drug Pages (1)

Sulfamethox-TMP DS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ea935f93-6c2d-2e8a-e053-2995a90a2ce0", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198335"], "spl_set_id": ["ede74118-32c5-4f52-9823-509538e674c8"], "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": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-625-06)  / 6 TABLET in 1 BOTTLE", "package_ndc": "54348-625-06", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-625-10)  / 10 TABLET in 1 BOTTLE", "package_ndc": "54348-625-10", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-625-14)  / 14 TABLET in 1 BOTTLE", "package_ndc": "54348-625-14", "marketing_start_date": "20190711"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-625-20)  / 20 TABLET in 1 BOTTLE", "package_ndc": "54348-625-20", "marketing_start_date": "20190711"}], "brand_name": "Sulfamethox-TMP DS", "product_id": "54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0", "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": "54348-625", "generic_name": "SULFAMETHOXAZOLE, TRIMETHOPRIM", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethox-TMP DS", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "800 mg/1"}, {"name": "TRIMETHOPRIM", "strength": "160 mg/1"}], "application_number": "ANDA076899", "marketing_category": "ANDA", "marketing_start_date": "20190711", "listing_expiration_date": "20261231"}