FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50090-2199
11-digit product format
500902199
Labeler code
50090
Product ID
50090-2199_e00777f6-c80e-490c-8f6a-ddb3375347c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-2199-02023-02-06C16284748780-1f386c64a-212e-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2199-12023-02-06C16284748780-1f386c64a-212e-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2199-02023-01-30C16284748780-1f386c64a-212e-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-2199-12023-01-30C16284748780-1f386c64a-212e-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2199-0Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET4015
50090-2199-1Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2199-0EA - Each50090-2199af11e038-9b47-4dff-a605-e2d3da8fbcb612019-02-13
50090-2199-1EA - Each50090-21992f99a7f5-b34f-435d-8b55-e6b568f365e612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2199SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20250403_4e12b7e1-fa2f-4cd1-ada6-19a7d5652348.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN4e12b7e1-fa2f-4cd1-ada6-19a7d565234815
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD4e12b7e1-fa2f-4cd1-ada6-19a7d565234815
198335SMX 800 MG / TMP 160 MG Oral TabletSY4e12b7e1-fa2f-4cd1-ada6-19a7d565234815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2199-05009021990040 TABLET in 1 BOTTLE (50090-2199-0) 40 tablet2015-10-280000-00-00NoNoCurrent
50090-2199-15009021990130 TABLET in 1 BOTTLE (50090-2199-1) 30 tablet2015-10-280000-00-00NoNoCurrent