FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
71205-810
11-digit product format
712050810
Labeler code
71205
Product ID
71205-810_2b902590-982d-43cc-b3a4-52cd9f7edf6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
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
71205-810-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET65
71205-810-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET105
71205-810-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET145
71205-810-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET205
71205-810-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET285
71205-810-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET305
71205-810-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET405
71205-810-60Sulfamethoxazole and Trimethoprim60 in 1 BOTTLETABLET605
71205-810-90Sulfamethoxazole and Trimethoprim90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-810SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5Current NDC, 9 package rows20230825_befcc5b0-04bb-4211-b3dd-88f400c7fa78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNbefcc5b0-04bb-4211-b3dd-88f400c7fa785
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDbefcc5b0-04bb-4211-b3dd-88f400c7fa785
198335SMX 800 MG / TMP 160 MG Oral TabletSYbefcc5b0-04bb-4211-b3dd-88f400c7fa785

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-810-06712050810066 TABLET in 1 BOTTLE (71205-810-06) 6 tablet2023-07-19NoNoCurrent
71205-810-107120508101010 TABLET in 1 BOTTLE (71205-810-10) 10 tablet2023-05-31NoNoCurrent
71205-810-147120508101414 TABLET in 1 BOTTLE (71205-810-14) 14 tablet2023-05-31NoNoCurrent
71205-810-207120508102020 TABLET in 1 BOTTLE (71205-810-20) 20 tablet2023-06-02NoNoCurrent
71205-810-287120508102828 TABLET in 1 BOTTLE (71205-810-28) 28 tablet2023-06-02NoNoCurrent
71205-810-307120508103030 TABLET in 1 BOTTLE (71205-810-30) 30 tablet2023-05-31NoNoCurrent
71205-810-407120508104040 TABLET in 1 BOTTLE (71205-810-40) 40 tablet2023-08-21NoNoCurrent
71205-810-607120508106060 TABLET in 1 BOTTLE (71205-810-60) 60 tablet2023-05-31NoNoCurrent
71205-810-907120508109090 TABLET in 1 BOTTLE (71205-810-90) 90 tablet2023-05-31NoNoCurrent