Sulfamethoxazole and Trimethoprim

Product NDC
45865-475
11-digit product format
458650475
Labeler code
45865
Product ID
45865-475_718c0dfc-15c1-92e0-e053-2995a90a3051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-09-13
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
45865-475-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET201
45865-475-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-475SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20180723_718c0dfc-15c0-92e0-e053-2995a90a3051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN718c0dfc-15c0-92e0-e053-2995a90a30511
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD718c0dfc-15c0-92e0-e053-2995a90a30511
198335SMX 800 MG / TMP 160 MG Oral TabletSY718c0dfc-15c0-92e0-e053-2995a90a30511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-475-204586504752020 TABLET in 1 BOTTLE (45865-475-20) 20 tablet2018-01-010000-00-00NoNoCurrent
45865-475-304586504753030 TABLET in 1 BOTTLE (45865-475-30) 30 tablet2018-01-010000-00-00NoNoCurrent