Sulfamethoxazole and Trimethoprim

Product NDC
83939-0023
11-digit product format
839390023
Labeler code
83939
Product ID
83939-0023_427ba449-5345-7f45-e063-6294a90a18cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
VERITYRX, 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
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
83939-0023-1Sulfamethoxazole and Trimethoprim1 in 1 POUCHTABLET11
83939-0023-2Sulfamethoxazole and Trimethoprim1 in 1 BOX, UNIT-DOSETABLET11
83939-0023-2Sulfamethoxazole and Trimethoprim50 in 1 BOX, UNIT-DOSETABLET501
83939-0023-3Sulfamethoxazole and Trimethoprim100 in 1 BOX, UNIT-DOSETABLET1001
83939-0023-3Sulfamethoxazole and Trimethoprim1 in 1 POUCHTABLET11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN427b8040-99a4-8e81-e063-6394a90a76c51
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD427b8040-99a4-8e81-e063-6394a90a76c51
198335SMX 800 MG / TMP 160 MG Oral TabletSY427b8040-99a4-8e81-e063-6394a90a76c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83939-0023-1839390023011 TABLET in 1 POUCH (83939-0023-1) 1 tablet2025-11-03NoNoHistorical
83939-0023-28393900230250 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0023-2) / 1 TABLET in 1 BOX, UNIT-DOSE2025-11-03NoNoHistorical
83939-0023-383939002303100 POUCH in 1 BOX, UNIT-DOSE (83939-0023-3) / 1 TABLET in 1 POUCH100 pouch2025-11-03NoNoHistorical