FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
60687-442
11-digit product format
606870442
Labeler code
60687
Product ID
60687-442_3546bee9-e4fa-333e-e063-6394a90a4200
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA091348
Marketing category
ANDA
Marketing start
2024-11-07
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
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
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
60687-442-24Sulfamethoxazole and Trimethoprim20 mL in 1 CUP, UNIT-DOSESUSPENSION203
60687-442-53Sulfamethoxazole and Trimethoprim10 in 1 TRAYSUSPENSION103
60687-442-75Sulfamethoxazole and Trimethoprim4 in 1 CASESUSPENSION43

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-442-24ML - Milliliter60687-4420704f966-2e77-4675-b65f-1d7436223c0612024-10-04
60687-442-75ML - Milliliter60687-442ae280cfa-66bc-438f-8bb0-2b83304334e612024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-442SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AMERICAN HEALTH PACKAGING]3Current NDC, 3 package rows20250521_f14b8d07-e73b-4ceb-bd6a-578c961b7c09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-442-246068704422420 mL in 1 CUP, UNIT-DOSE20 mlHistorical
60687-442-536068704425310 in 1 TRAYHistorical
60687-442-75606870442754 TRAY in 1 CASE (60687-442-75) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-442-53) / 20 mL in 1 CUP, UNIT-DOSE (60687-442-24) 4 tray2024-11-07NoNoHistorical