FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
63187-782
11-digit product format
631870782
Labeler code
63187
Product ID
63187-782_5a945d95-78e5-470a-8567-5021043a3db6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-09-13
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
63187-782-06Sulfamethoxazole and Trimethoprim06 in 1 BOTTLETABLET062
63187-782-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET102
63187-782-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET142
63187-782-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET202
63187-782-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET282
63187-782-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-782SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20191128_0df74ba1-1aa6-467c-92e7-6b017c7c6bce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN0df74ba1-1aa6-467c-92e7-6b017c7c6bce2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD0df74ba1-1aa6-467c-92e7-6b017c7c6bce2
198335SMX 800 MG / TMP 160 MG Oral TabletSY0df74ba1-1aa6-467c-92e7-6b017c7c6bce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-782-06631870782066 TABLET in 1 BOTTLE (63187-782-06) 6 tablet2016-11-010000-00-00NoNoCurrent
63187-782-106318707821010 TABLET in 1 BOTTLE (63187-782-10) 10 tablet2016-11-010000-00-00NoNoCurrent
63187-782-146318707821414 TABLET in 1 BOTTLE (63187-782-14) 14 tablet2016-11-010000-00-00NoNoCurrent
63187-782-206318707822020 TABLET in 1 BOTTLE (63187-782-20) 20 tablet2016-11-010000-00-00NoNoCurrent
63187-782-286318707822828 TABLET in 1 BOTTLE (63187-782-28) 28 tablet2016-11-010000-00-00NoNoCurrent
63187-782-406318707824040 TABLET in 1 BOTTLE (63187-782-40) 40 tablet2016-11-010000-00-00NoNoCurrent