Sulfamethoxazole and Trimethoprim

Product NDC
55154-7895
11-digit product format
551547895
Labeler code
55154
Product ID
55154-7895_c13ff702-7c1e-433d-9b59-f2c6929842c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-09-13
Marketing end
2027-03-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim

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
55154-7895-0Sulfamethoxazole and Trimethoprim1 in 1 BLISTER PACKTABLET18
55154-7895-0Sulfamethoxazole and Trimethoprim10 in 1 BAGTABLET108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7895SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [CARDINAL HEALTH 107, LLC]6Current NDC, Legacy NDC, 2 package rows20250305_5dc03027-cdaf-461f-87fd-630d382fc723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN5dc03027-cdaf-461f-87fd-630d382fc7238
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD5dc03027-cdaf-461f-87fd-630d382fc7238
198335SMX 800 MG / TMP 160 MG Oral TabletSY5dc03027-cdaf-461f-87fd-630d382fc7238

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7895-05515478950010 BLISTER PACK in 1 BAG (55154-7895-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2010-09-132027-03-31NoNoCurrent