FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
68788-8607
11-digit product format
687888607
Labeler code
68788
Product ID
68788-8607_ddc0cf94-05e0-42e0-9a4f-d79cfb3c1be9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214330
Marketing category
ANDA
Marketing start
2024-03-14
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
68788-8607-4Sulfamethoxazole and Trimethoprim473 mL in 1 BOTTLESUSPENSION4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8607-4ML - Milliliter68788-86073c59f605-453d-48df-a202-56e97772a68c12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8607SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 1 package rows20240402_c6171b62-835c-465e-905e-97f70438186e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNc6171b62-835c-465e-905e-97f70438186e2
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDc6171b62-835c-465e-905e-97f70438186e2
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYc6171b62-835c-465e-905e-97f70438186e2
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYc6171b62-835c-465e-905e-97f70438186e2
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYc6171b62-835c-465e-905e-97f70438186e2
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYc6171b62-835c-465e-905e-97f70438186e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8607-468788860704473 mL in 1 BOTTLE (68788-8607-4) 473 ml2024-03-14NoNoHistorical