FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
70518-2604
11-digit product format
705182604
Labeler code
70518
Product ID
70518-2604_4a6a1c66-916a-8ea9-e063-6394a90aa480
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2020-02-28
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
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
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
70518-2604-0Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET1425
70518-2604-1Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET2025
70518-2604-2Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET625
70518-2604-3Sulfamethoxazole and Trimethoprim14 in 1 BLISTER PACKTABLET1425
70518-2604-4Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET2025
70518-2604-5Sulfamethoxazole and Trimethoprim30 in 1 BLISTER PACKTABLET3025
70518-2604-6Sulfamethoxazole and Trimethoprim20 in 1 BLISTER PACKTABLET2025
70518-2604-7Sulfamethoxazole and Trimethoprim21 in 1 BOTTLE, PLASTICTABLET2125
70518-2604-8Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET1425
70518-2604-9Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET1025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2604SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REMEDYREPACK INC.]22Current NDC, Legacy NDC, 10 package rows20250202_c45ac3a4-d397-486e-abd1-349916543068.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNc45ac3a4-d397-486e-abd1-34991654306825
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDc45ac3a4-d397-486e-abd1-34991654306825
198335SMX 800 MG / TMP 160 MG Oral TabletSYc45ac3a4-d397-486e-abd1-34991654306825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2604-07051826040014 TABLET in 1 BOTTLE, PLASTIC (70518-2604-0) 14 tablet2020-02-280000-00-00NoNoCurrent
70518-2604-17051826040120 TABLET in 1 BOTTLE, PLASTIC (70518-2604-1) 20 tablet2020-07-300000-00-00NoNoCurrent
70518-2604-2705182604026 TABLET in 1 BOTTLE, PLASTIC (70518-2604-2) 6 tablet2021-03-010000-00-00NoNoCurrent
70518-2604-37051826040314 TABLET in 1 BLISTER PACK (70518-2604-3) 14 tablet2022-03-070000-00-00NoNoCurrent
70518-2604-47051826040420 TABLET in 1 BOTTLE, PLASTIC (70518-2604-4) 20 tablet2022-03-110000-00-00NoNoCurrent
70518-2604-57051826040530 TABLET in 1 BLISTER PACK (70518-2604-5) 30 tablet2022-03-170000-00-00NoNoCurrent
70518-2604-67051826040620 TABLET in 1 BLISTER PACK (70518-2604-6) 20 tablet2022-04-120000-00-00NoNoCurrent
70518-2604-77051826040721 TABLET in 1 BOTTLE, PLASTIC (70518-2604-7) 21 tablet2022-05-110000-00-00NoNoCurrent
70518-2604-87051826040814 TABLET in 1 BOTTLE, PLASTIC (70518-2604-8) 14 tablet2022-05-270000-00-00NoNoCurrent
70518-2604-97051826040910 TABLET in 1 BOTTLE, PLASTIC (70518-2604-9) 10 tablet2022-06-070000-00-00NoNoCurrent