FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
69043-011
11-digit product format
690430011
Labeler code
69043
Product ID
69043-011_17de019d-ffdf-436a-bcae-2941f844123a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Cronus Pharma LLC
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
UniiAN164J8Y0X, JE42381TNV
Rxcui198334, 198335

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69043-011-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1008
69043-011-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69043-011SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CRONUS PHARMA LLC]8Current NDC, Legacy NDC, 2 package rows20250410_1b5de94f-973a-4b5a-91d7-45e05be78650.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN1b5de94f-973a-4b5a-91d7-45e05be786508
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN1b5de94f-973a-4b5a-91d7-45e05be786508
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD1b5de94f-973a-4b5a-91d7-45e05be786508
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD1b5de94f-973a-4b5a-91d7-45e05be786508
198334SMX 400 MG / TMP 80 MG Oral TabletSY1b5de94f-973a-4b5a-91d7-45e05be786508
198335SMX 800 MG / TMP 160 MG Oral TabletSY1b5de94f-973a-4b5a-91d7-45e05be786508

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69043-011-0169043001101100 TABLET in 1 BOTTLE (69043-011-01) 100 tablet2010-02-160000-00-00NoNoCurrent
69043-011-0569043001105500 TABLET in 1 BOTTLE (69043-011-05) 500 tablet2010-02-160000-00-00NoNoCurrent