FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
67296-1129
11-digit product format
672961129
Labeler code
67296
Product ID
67296-1129_d60feb9c-08c1-7a56-e053-2995a90a7892
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091348
Marketing category
ANDA
Marketing start
2010-06-08
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200 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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1129-12026-01-29C16284748780-11030e365-1526-111a-e063-dadaa90a10e24eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-22026-01-29C16284748780-11030e365-1526-111a-e063-dadaa90a10e24eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-12024-07-15C16284748780-11030e365-1526-111a-e063-dadaa90a10e24eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-22024-07-15C16284748780-11030e365-1526-111a-e063-dadaa90a10e24eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-12024-01-30C16284748780-11030e365-1526-111a-e063-dadaa90a10e24eb60cd1-612c-20ab-e054-00144ff88e88
67296-1129-22024-01-30C16284748780-11030e365-1526-111a-e063-dadaa90a10e24eb60cd1-612c-20ab-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1129-1Sulfamethoxazole and Trimethoprim100 mL in 1 BOTTLESUSPENSION1006
67296-1129-2Sulfamethoxazole and Trimethoprim200 mL in 1 BOTTLESUSPENSION2006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1129SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [REDPHARM DRUG, INC.]6Legacy NDC, 2 package rows20240716_4eb60cd1-612c-20ab-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD4eb60cd1-612c-20ab-e054-00144ff88e886
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY4eb60cd1-612c-20ab-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1129-167296112901100 mL in 1 BOTTLE (67296-1129-1) 100 ml2010-06-080000-00-00NoNoCurrent
67296-1129-267296112902200 mL in 1 BOTTLE (67296-1129-2) 200 ml2010-06-080000-00-00NoNoCurrent