FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
80425-0003
11-digit product format
804250003
Labeler code
80425
Product ID
80425-0003_2a98001f-209b-c78f-e063-6294a90a1067
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800; 160 mg/1; mg/1
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Brand name suffix
DS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE800 mg/1
TRIMETHOPRIM160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui198335

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0003-1Sulfamethoxazole and TrimethoprimDS14 in 1 BOTTLETABLET148
80425-0003-2Sulfamethoxazole and TrimethoprimDS20 in 1 BOTTLETABLET208
80425-0003-3Sulfamethoxazole and TrimethoprimDS30 in 1 BOTTLETABLET308
80425-0003-4Sulfamethoxazole and TrimethoprimDS10 in 1 BOTTLETABLET108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0003-1EA - Each80425-0003b395dd6b-a026-42cd-88c5-a50d83685b8e12023-06-06
80425-0003-2EA - Each80425-000307d01817-0eca-4bcf-b3ae-0265292b4ff112023-06-06
80425-0003-3EA - Each80425-00035c57bd33-3294-49d2-b115-d9af8005151112023-06-06
80425-0003-4EA - Each80425-0003af211f41-02d0-4972-bc79-7072a633ad0712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0003SULFAMETHOXAZOLE AND TRIMETHOPRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]8Current NDC, Legacy NDC, 4 package rows20250101_afe8cb1c-7cfd-3378-e053-2a95a90a4db6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNafe8cb1c-7cfd-3378-e053-2a95a90a4db68
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDafe8cb1c-7cfd-3378-e053-2a95a90a4db68
198335SMX 800 MG / TMP 160 MG Oral TabletSYafe8cb1c-7cfd-3378-e053-2a95a90a4db68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0003-18042500030114 TABLET in 1 BOTTLE (80425-0003-1) 14 tablet2010-02-160000-00-00NoNoCurrent
80425-0003-28042500030220 TABLET in 1 BOTTLE (80425-0003-2) 20 tablet2010-02-160000-00-00NoNoCurrent
80425-0003-38042500030330 TABLET in 1 BOTTLE (80425-0003-3) 30 tablet2010-02-160000-00-00NoNoCurrent
80425-0003-48042500030410 TABLET in 1 BOTTLE (80425-0003-4) 10 tablet2010-02-16NoNoCurrent