FDA.reportPublic FDA data

SULFATRIM

Product NDC
50090-7836
11-digit product format
500907836
Labeler code
50090
Product ID
50090-7836_582e04ab-98bc-46c8-8e39-ccd2dccd4c2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA018615
Marketing category
NDA
Marketing start
1983-07-03
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200; 40 mg/5mL; mg/5mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SULFATRIM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE200 mg/5mL
TRIMETHOPRIM40 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui208406, 313134

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
50090-7836-0SULFATRIM473 mL in 1 BOTTLESUSPENSION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7836-0ML - Milliliter50090-7836a2e4527b-1c51-4af5-9a11-2c72131064f512026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN80f7f00b-add4-4d6b-9e9c-bea29768c2392
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSN80f7f00b-add4-4d6b-9e9c-bea29768c2392
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBD80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SY80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7836-050090783600473 mL in 1 BOTTLE (50090-7836-0) 473 ml2025-12-29NoNoHistorical