Sulfamethoxazole and Trimethoprim

Product NDC
67296-0387
11-digit product format
672960387
Labeler code
67296
Product ID
67296-0387_d5fc2560-df27-e0f6-e053-2a95a90a5ef8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA071017
Marketing category
ANDA
Marketing start
1986-08-25
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
67296-0387-1Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET105
67296-0387-2Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET65
67296-0387-3Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET205
67296-0387-4Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0387SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REDPHARM DRUG, INC.]5Legacy NDC, 4 package rows20240711_4196e73b-5aec-2ede-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN4196e73b-5aec-2ede-e054-00144ff8d46c5
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD4196e73b-5aec-2ede-e054-00144ff8d46c5
198335SMX 800 MG / TMP 160 MG Oral TabletSY4196e73b-5aec-2ede-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0387-16729603870110 TABLET in 1 BOTTLE (67296-0387-1) 10 tablet1986-08-250000-00-00NoNoCurrent
67296-0387-2672960387026 TABLET in 1 BOTTLE (67296-0387-2) 6 tablet1986-08-250000-00-00NoNoCurrent
67296-0387-36729603870320 TABLET in 1 BOTTLE (67296-0387-3) 20 tablet1986-08-250000-00-00NoNoCurrent
67296-0387-46729603870414 TABLET in 1 BOTTLE (67296-0387-4) 14 tablet1986-08-250000-00-00NoNoCurrent