FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
42291-758
11-digit product format
422910758
Labeler code
42291
Product ID
42291-758_4a7ee07f-6eea-dd30-e063-6394a90adac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA076899
Marketing category
ANDA
Marketing start
2015-08-05
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, 198335

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
42291-758-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10012
42291-758-50Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET50012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-758SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVKARE]10Current NDC, Legacy NDC, 2 package rows20240111_9f130443-c8e7-9122-8f27-f72f07f3f29e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN9f130443-c8e7-9122-8f27-f72f07f3f29e12
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD9f130443-c8e7-9122-8f27-f72f07f3f29e12
198334SMX 400 MG / TMP 80 MG Oral TabletSY9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335SMX 800 MG / TMP 160 MG Oral TabletSY9f130443-c8e7-9122-8f27-f72f07f3f29e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-758-0142291075801100 TABLET in 1 BOTTLE (42291-758-01) 100 tablet2015-08-050000-00-00NoNoCurrent
42291-758-5042291075850500 TABLET in 1 BOTTLE (42291-758-50) 500 tablet2016-10-310000-00-00NoNoCurrent