FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
63187-008
11-digit product format
631870008
Labeler code
63187
Product ID
63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076817
Marketing category
ANDA
Marketing start
2006-08-22
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800; 160 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
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
SULFAMETHOXAZOLE800 mg/1
TRIMETHOPRIM160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui198335

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
63187-008-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET68
63187-008-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET108
63187-008-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET148
63187-008-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET208
63187-008-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET288
63187-008-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET408

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-008SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]8Current NDC, Legacy NDC, 6 package rows20221018_c407381f-3d8e-4fdf-9132-cd3968099296.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNc407381f-3d8e-4fdf-9132-cd39680992968
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDc407381f-3d8e-4fdf-9132-cd39680992968
198335SMX 800 MG / TMP 160 MG Oral TabletSYc407381f-3d8e-4fdf-9132-cd39680992968

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-008-06631870008066 TABLET in 1 BOTTLE (63187-008-06) 6 tablet2018-11-010000-00-00NoNoCurrent
63187-008-106318700081010 TABLET in 1 BOTTLE (63187-008-10) 10 tablet2018-11-010000-00-00NoNoCurrent
63187-008-146318700081414 TABLET in 1 BOTTLE (63187-008-14) 14 tablet2018-11-010000-00-00NoNoCurrent
63187-008-206318700082020 TABLET in 1 BOTTLE (63187-008-20) 20 tablet2018-11-010000-00-00NoNoCurrent
63187-008-286318700082828 TABLET in 1 BOTTLE (63187-008-28) 28 tablet2018-11-010000-00-00NoNoCurrent
63187-008-406318700084040 TABLET in 1 BOTTLE (63187-008-40) 40 tablet2018-11-010000-00-00NoNoCurrent