FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
70518-3454
11-digit product format
705183454
Labeler code
70518
Product ID
70518-3454_51266d92-fbe7-c471-e063-6394a90a8dd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2022-07-18
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
400; 80 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE400 mg/1
TRIMETHOPRIM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui198334

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
70518-3454-0Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET611
70518-3454-1Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET1411
70518-3454-2Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET611
70518-3454-3Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET2011
70518-3454-4Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3454SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20241023_ce44959b-4bfe-4ba9-9fc2-7f9d4663d542.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNce44959b-4bfe-4ba9-9fc2-7f9d4663d54211
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDce44959b-4bfe-4ba9-9fc2-7f9d4663d54211
198334SMX 400 MG / TMP 80 MG Oral TabletSYce44959b-4bfe-4ba9-9fc2-7f9d4663d54211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3454-0705183454006 TABLET in 1 BOTTLE, PLASTIC (70518-3454-0) 6 tablet2022-07-180000-00-00NoNoCurrent
70518-3454-17051834540114 in 1 BOTTLE, PLASTICHistorical
70518-3454-2705183454026 in 1 BOTTLE, PLASTICHistorical
70518-3454-37051834540320 TABLET in 1 BOTTLE, PLASTIC (70518-3454-3) 20 tablet2025-07-01NoNoHistorical
70518-3454-47051834540410 TABLET in 1 BOTTLE, PLASTIC (70518-3454-4) 10 tablet2025-08-06NoNoHistorical