FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
85766-015
11-digit product format
857660015
Labeler code
85766
Product ID
85766-015_49ef26b9-b7b9-bfa8-e063-6394a90a0c50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm 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
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
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
85766-015-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1002
85766-015-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET5002
85766-015-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET62
85766-015-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET102
85766-015-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET142
85766-015-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET202
85766-015-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET282
85766-015-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN52304e5e-d097-48f2-8b64-210908e4eb542
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD52304e5e-d097-48f2-8b64-210908e4eb542
198335SMX 800 MG / TMP 160 MG Oral TabletSY52304e5e-d097-48f2-8b64-210908e4eb542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-015-0185766001501100 TABLET in 1 BOTTLE (85766-015-01) 100 tablet2025-06-20NoNoCurrent
85766-015-0585766001505500 TABLET in 1 BOTTLE (85766-015-05) 500 tablet2025-06-20NoNoCurrent
85766-015-06857660015066 TABLET in 1 BOTTLE (85766-015-06) 6 tablet2025-06-20NoNoCurrent
85766-015-108576600151010 TABLET in 1 BOTTLE (85766-015-10) 10 tablet2025-06-20NoNoCurrent
85766-015-148576600151414 TABLET in 1 BOTTLE (85766-015-14) 14 tablet2025-06-20NoNoCurrent
85766-015-208576600152020 TABLET in 1 BOTTLE (85766-015-20) 20 tablet2025-06-20NoNoCurrent
85766-015-288576600152828 TABLET in 1 BOTTLE (85766-015-28) 28 tablet2025-06-20NoNoCurrent
85766-015-308576600153030 TABLET in 1 BOTTLE (85766-015-30) 30 tablet2025-06-20NoNoCurrent