sulfamethoxazole and trimethoprim

Generic: sulfamethoxazole and trimethoprim

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfamethoxazole and trimethoprim
Generic Name sulfamethoxazole and trimethoprim
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sulfamethoxazole 800 mg/1, trimethoprim 160 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-272
Product ID 53746-272_bc5fe496-071b-4c25-95da-14c6c561e79e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076899
Listing Expiration 2026-12-31
Marketing Start 2010-09-13

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 53746272
Hyphenated Format 53746-272

Supplemental Identifiers

RxCUI
198334 198335
UPC
0353746271013 0353746272010
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 ANDA076899 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-272-01)
  • 250 TABLET in 1 BOTTLE (53746-272-02)
  • 500 TABLET in 1 BOTTLE (53746-272-05)
  • 10 TABLET in 1 BOTTLE (53746-272-11)
  • 24 TABLET in 1 BOTTLE (53746-272-24)
source: ndc

Packages (5)

53746-272-01 100 TABLET in 1 BOTTLE (53746-272-01) 53746-272-02 250 TABLET in 1 BOTTLE (53746-272-02) 53746-272-05 500 TABLET in 1 BOTTLE (53746-272-05) 53746-272-11 10 TABLET in 1 BOTTLE (53746-272-11) 53746-272-24 24 TABLET in 1 BOTTLE (53746-272-24)

Ingredients (2)

sulfamethoxazole (800 mg/1) trimethoprim (160 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": "bc5fe496-071b-4c25-95da-14c6c561e79e", "openfda": {"nui": ["N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504"], "upc": ["0353746271013", "0353746272010"], "unii": ["AN164J8Y0X", "JE42381TNV"], "rxcui": ["198334", "198335"], "spl_set_id": ["3233c54d-484d-4550-b172-db8af47d1b7f"], "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": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-272-01)", "package_ndc": "53746-272-01", "marketing_start_date": "20100913"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (53746-272-02)", "package_ndc": "53746-272-02", "marketing_start_date": "20100913"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-272-05)", "package_ndc": "53746-272-05", "marketing_start_date": "20100913"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (53746-272-11)", "package_ndc": "53746-272-11", "marketing_start_date": "20100913"}, {"sample": false, "description": "24 TABLET in 1 BOTTLE (53746-272-24)", "package_ndc": "53746-272-24", "marketing_start_date": "20100913"}], "brand_name": "Sulfamethoxazole and Trimethoprim", "product_id": "53746-272_bc5fe496-071b-4c25-95da-14c6c561e79e", "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": "53746-272", "generic_name": "Sulfamethoxazole and Trimethoprim", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfamethoxazole and Trimethoprim", "active_ingredients": [{"name": "SULFAMETHOXAZOLE", "strength": "800 mg/1"}, {"name": "TRIMETHOPRIM", "strength": "160 mg/1"}], "application_number": "ANDA076899", "marketing_category": "ANDA", "marketing_start_date": "20100913", "listing_expiration_date": "20261231"}