sulfameth/trimeth-ds

Generic: sulfameth/trimeth-ds

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfameth/trimeth-ds
Generic Name sulfameth/trimeth-ds
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-645
Product ID 61919-645_47e154aa-d636-469b-e063-6394a90ad9b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090624
Listing Expiration 2027-12-31
Marketing Start 2019-08-13

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 61919645
Hyphenated Format 61919-645

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 sulfameth/trimeth-ds (source: ndc)
Generic Name sulfameth/trimeth-ds (source: ndc)
Application Number ANDA090624 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 6 TABLET in 1 BOTTLE (61919-645-06)
  • 30 TABLET in 1 BOTTLE (61919-645-30)
  • 56 TABLET in 1 BOTTLE (61919-645-56)
  • 60 TABLET in 1 BOTTLE (61919-645-60)
source: ndc

Packages (4)

61919-645-06 6 TABLET in 1 BOTTLE (61919-645-06) 61919-645-30 30 TABLET in 1 BOTTLE (61919-645-30) 61919-645-56 56 TABLET in 1 BOTTLE (61919-645-56) 61919-645-60 60 TABLET in 1 BOTTLE (61919-645-60)

Ingredients (2)

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

Linked Drug Pages (1)

Sulfameth/Trimeth-DS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e154aa-d636-469b-e063-6394a90ad9b9", "openfda": {"nui": ["N0000175504", "M0020790", "N0000185504", "N0000175489", "N0000000191", "N0000187062", "N0000187061"], "unii": ["JE42381TNV", "AN164J8Y0X"], "rxcui": ["198335"], "spl_set_id": ["90026ce8-3305-6272-e053-2995a90a57e0"], "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": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET in 1 BOTTLE (61919-645-06)", "package_ndc": "61919-645-06", "marketing_start_date": "20190813"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (61919-645-30)", "package_ndc": "61919-645-30", "marketing_start_date": "20190813"}, {"sample": false, "description": "56 TABLET in 1 BOTTLE (61919-645-56)", "package_ndc": "61919-645-56", "marketing_start_date": "20190813"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (61919-645-60)", "package_ndc": "61919-645-60", "marketing_start_date": "20190813"}], "brand_name": "Sulfameth/Trimeth-DS", "product_id": "61919-645_47e154aa-d636-469b-e063-6394a90ad9b9", "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": "61919-645", "generic_name": "Sulfameth/Trimeth-DS", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfameth/Trimeth-DS", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "800 mg/1"}, {"name": "TRIMETHOPRIM", "strength": "160 mg/1"}], "application_number": "ANDA090624", "marketing_category": "ANDA", "marketing_start_date": "20190813", "listing_expiration_date": "20271231"}