FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
72789-018
11-digit product format
727890018
Labeler code
72789
Product ID
72789-018_3143fb81-1052-c193-e063-6394a90a18e8
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
72789-018-02Sulfamethoxazole and Trimethoprim2 in 1 BOTTLE, PLASTICTABLET226
72789-018-04Sulfamethoxazole and Trimethoprim4 in 1 BOTTLE, PLASTICTABLET426
72789-018-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLE, PLASTICTABLET626
72789-018-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLE, PLASTICTABLET1026
72789-018-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLE, PLASTICTABLET1426
72789-018-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLE, PLASTICTABLET2026
72789-018-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLE, PLASTICTABLET2826
72789-018-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLE, PLASTICTABLET4026
72789-018-60Sulfamethoxazole and Trimethoprim60 in 1 BOTTLE, PLASTICTABLET6026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-018-02EA - Each72789-018ede706d1-dd84-4944-8a17-a6267099957812020-07-13
72789-018-04EA - Each72789-0180b12ebae-d70b-452f-94cf-3b3bdc05905812020-04-20
72789-018-06EA - Each72789-018b290d461-35be-4548-abc7-2293e3cf3b5612020-01-03
72789-018-10EA - Each72789-018ed380a50-6651-4210-8e15-16cb81fb7b2a12020-01-03
72789-018-14EA - Each72789-01804bd23bc-eb79-40ba-a291-7ec8a2b6d8b912020-01-03
72789-018-20EA - Each72789-018b80433c7-6624-41e9-acf0-cd82c52592de12020-01-03
72789-018-28EA - Each72789-0185936227f-78b8-4bd7-b9e2-86216431bb2912020-04-20
72789-018-40EA - Each72789-0180b4285a5-af9c-4b66-a9c3-c57e9efc851512020-01-03
72789-018-60EA - Each72789-018c1511091-d7da-4e90-a9da-823e9524a86b12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-018SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 9 package rows20250328_3ef62512-0dc3-4821-9b60-6b375841c4c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3ef62512-0dc3-4821-9b60-6b375841c4c026
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3ef62512-0dc3-4821-9b60-6b375841c4c026
198335SMX 800 MG / TMP 160 MG Oral TabletSY3ef62512-0dc3-4821-9b60-6b375841c4c026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-018-02727890018022 TABLET in 1 BOTTLE, PLASTIC (72789-018-02) 2 tablet2020-04-100000-00-00NoNoCurrent
72789-018-04727890018044 TABLET in 1 BOTTLE, PLASTIC (72789-018-04) 4 tablet2020-02-260000-00-00NoNoCurrent
72789-018-06727890018066 TABLET in 1 BOTTLE, PLASTIC (72789-018-06) 6 tablet2019-10-170000-00-00NoNoCurrent
72789-018-107278900181010 TABLET in 1 BOTTLE, PLASTIC (72789-018-10) 10 tablet2019-10-290000-00-00NoNoCurrent
72789-018-147278900181414 TABLET in 1 BOTTLE, PLASTIC (72789-018-14) 14 tablet2019-11-010000-00-00NoNoCurrent
72789-018-207278900182020 TABLET in 1 BOTTLE, PLASTIC (72789-018-20) 20 tablet2019-10-170000-00-00NoNoCurrent
72789-018-287278900182828 TABLET in 1 BOTTLE, PLASTIC (72789-018-28) 28 tablet2020-02-130000-00-00NoNoCurrent
72789-018-407278900184040 TABLET in 1 BOTTLE, PLASTIC (72789-018-40) 40 tablet2019-11-220000-00-00NoNoCurrent
72789-018-607278900186060 TABLET in 1 BOTTLE, PLASTIC (72789-018-60) 60 tablet2019-10-170000-00-00NoNoCurrent