FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50090-0525
11-digit product format
500900525
Labeler code
50090
Product ID
50090-0525_6b5fe102-d381-4461-aaa6-61a1f6679d39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091348
Marketing category
ANDA
Marketing start
2010-06-08
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
Sulfamethoxazole and Trimethoprim
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
Rxcui313134

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
50090-0525-0Sulfamethoxazole and Trimethoprim473 mL in 1 BOTTLESUSPENSION47316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0525-0ML - Milliliter50090-052533874a48-fbe6-46f4-bd1e-58e49b766f4f12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0525SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 1 package rows20231024_69af86b4-9c9f-4a70-b448-97b36698f3cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY69af86b4-9c9f-4a70-b448-97b36698f3cd16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0525-050090052500473 mL in 1 BOTTLE (50090-0525-0) 473 ml2016-06-290000-00-00NoNoCurrent