FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50090-5682
11-digit product format
500905682
Labeler code
50090
Product ID
50090-5682_411b5f8e-1ab3-4603-a28c-9fc63e1f8e1e
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5682-0Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET403
50090-5682-1Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5682-0EA - Each50090-5682a38b84d6-4779-43d5-910d-227d9286886612023-06-06
50090-5682-1EA - Each50090-568250fb6198-aa2b-400a-9bc4-c3f25e9aee9812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5682SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20250227_20054147-811c-471a-8ec4-1b2903fe906e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN20054147-811c-471a-8ec4-1b2903fe906e3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD20054147-811c-471a-8ec4-1b2903fe906e3
198335SMX 800 MG / TMP 160 MG Oral TabletSY20054147-811c-471a-8ec4-1b2903fe906e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-5682-05009056820040 TABLET in 1 BOTTLE (50090-5682-0) 40 tablet2021-09-21NoNoHistorical
50090-5682-15009056820130 TABLET in 1 BOTTLE (50090-5682-1) 30 tablet2021-09-21NoNoHistorical