FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
70518-3432
11-digit product format
705183432
Labeler code
70518
Product ID
70518-3432_48316d46-7ebd-938e-e063-6394a90a5ab5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2022-06-08
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
70518-3432-0Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET1010
70518-3432-1Sulfamethoxazole and Trimethoprim100 in 1 BOXTABLET10010
70518-3432-2Sulfamethoxazole and Trimethoprim1 in 1 POUCHTABLET110
70518-3432-3Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET610
70518-3432-4Sulfamethoxazole and Trimethoprim28 in 1 BOTTLE, PLASTICTABLET2810
70518-3432-5Sulfamethoxazole and Trimethoprim30 in 1 BOTTLE, PLASTICTABLET3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3432SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 6 package rows20241116_ec2e335c-3357-40d8-9615-a09fc40ce5f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNec2e335c-3357-40d8-9615-a09fc40ce5f410
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDec2e335c-3357-40d8-9615-a09fc40ce5f410
198335SMX 800 MG / TMP 160 MG Oral TabletSYec2e335c-3357-40d8-9615-a09fc40ce5f410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3432-07051834320010 TABLET in 1 BOTTLE, PLASTIC (70518-3432-0) 10 tablet2022-06-080000-00-00NoNoCurrent
70518-3432-170518343201100 POUCH in 1 BOX (70518-3432-1) / 1 TABLET in 1 POUCH (70518-3432-2) 100 pouch2023-01-040000-00-00NoNoCurrent
70518-3432-2705183432021 in 1 POUCHHistorical
70518-3432-3705183432036 TABLET in 1 BOTTLE, PLASTIC (70518-3432-3) 6 tablet2023-02-16NoNoHistorical
70518-3432-47051834320428 TABLET in 1 BOTTLE, PLASTIC (70518-3432-4) 28 tablet2023-12-23NoNoHistorical
70518-3432-57051834320530 TABLET in 1 BOTTLE, PLASTIC (70518-3432-5) 30 tablet2024-04-29NoNoHistorical