Sulfamethoxazole and Trimethoprim

Product NDC
67296-0724
11-digit product format
672960724
Labeler code
67296
Product ID
67296-0724_d60cd989-0dc5-44ba-e053-2a95a90ae7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076817
Marketing category
ANDA
Marketing start
2006-08-22
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0724-1Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET104
67296-0724-2Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET204
67296-0724-3Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET144
67296-0724-6Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0724SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REDPHARM DRUG, INC.]4Legacy NDC, 4 package rows20240712_4180c1d6-1aac-470e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN4180c1d6-1aac-470e-e054-00144ff88e884
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD4180c1d6-1aac-470e-e054-00144ff88e884
198335SMX 800 MG / TMP 160 MG Oral TabletSY4180c1d6-1aac-470e-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0724-16729607240110 TABLET in 1 BOTTLE (67296-0724-1) 10 tablet2006-08-220000-00-00NoNoCurrent
67296-0724-26729607240220 TABLET in 1 BOTTLE (67296-0724-2) 20 tablet2006-08-220000-00-00NoNoCurrent
67296-0724-36729607240314 TABLET in 1 BOTTLE (67296-0724-3) 14 tablet2006-08-220000-00-00NoNoCurrent
67296-0724-6672960724066 TABLET in 1 BOTTLE (67296-0724-6) 6 tablet2006-08-220000-00-00NoNoCurrent