FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
72789-064
11-digit product format
727890064
Labeler code
72789
Product ID
72789-064_3403cd92-3140-e0c6-e063-6294a90a5a1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
72789-064-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET620
72789-064-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET1420
72789-064-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET2020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-064-06EA - Each72789-06496e71eea-6669-4ec7-9a07-4de0a4b4e7a912020-05-08
72789-064-14EA - Each72789-064a1ed62a6-ffc7-44ed-99fa-c0b65ffc655e12024-08-12
72789-064-20EA - Each72789-06496f2fe01-7234-460e-874b-55a9809acfd812020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-064SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 3 package rows20250502_c4da9c4f-0704-4ed5-9d19-5c949f37f726.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNc4da9c4f-0704-4ed5-9d19-5c949f37f72620
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDc4da9c4f-0704-4ed5-9d19-5c949f37f72620
198335SMX 800 MG / TMP 160 MG Oral TabletSYc4da9c4f-0704-4ed5-9d19-5c949f37f72620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-064-06727890064066 TABLET in 1 BOTTLE, PLASTIC (72789-064-06) 6 tablet2020-03-230000-00-00NoNoCurrent
72789-064-147278900641414 TABLET in 1 BOTTLE, PLASTIC (72789-064-14) 14 tablet2024-07-03NoNoHistorical
72789-064-207278900642020 TABLET in 1 BOTTLE, PLASTIC (72789-064-20) 20 tablet2020-03-230000-00-00NoNoCurrent