FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
42708-053
11-digit product format
427080053
Labeler code
42708
Product ID
42708-053_45866c8f-2d1c-a0f4-e063-6394a90a5e4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
QPharma, Inc.
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42708-053-202021-03-12C16284748780-1ba0f9c33-303f-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP
42708-053-202021-01-29C16284748780-1ba0f9c33-303f-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-053-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42708-053SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [QPHARMA, INC.]6Current NDC, Legacy NDC, 1 package rows20250521_41529314-b203-47f4-88dd-5aa57c74985f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN41529314-b203-47f4-88dd-5aa57c74985f7
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD41529314-b203-47f4-88dd-5aa57c74985f7
198335SMX 800 MG / TMP 160 MG Oral TabletSY41529314-b203-47f4-88dd-5aa57c74985f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42708-053-204270800532020 TABLET in 1 BOTTLE (42708-053-20) 20 tablet2018-03-140000-00-00YesNoCurrent