FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
0121-0853
11-digit product format
001210853
Labeler code
0121
Product ID
0121-0853_533790e4-bcfb-447d-9665-0457f3c10c2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
NDA018615
Marketing category
NDA
Marketing start
2024-08-05
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200; 40 mg/5mL; mg/5mL
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
SULFAMETHOXAZOLE200 mg/5mL
TRIMETHOPRIM40 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui313134

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
0121-0853-20Sulfamethoxazole and Trimethoprim10 in 1 TRAYSUSPENSION106
0121-0853-20Sulfamethoxazole and Trimethoprim20 mL in 1 CUP, UNIT-DOSESUSPENSION206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0853-20ML - Milliliter0121-08531a7a683f-f8ba-4584-8636-9e10b45dcbec12018-11-06
0121-0853-40ML - Milliliter0121-0853a7a7e6c1-2927-432b-a657-0a723efac8ba12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0853SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]6Current NDC, Legacy NDC, 2 package rows20240823_777da85a-a776-4681-976d-326ec421cfc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN777da85a-a776-4681-976d-326ec421cfc96
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD777da85a-a776-4681-976d-326ec421cfc96
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY777da85a-a776-4681-976d-326ec421cfc96
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY777da85a-a776-4681-976d-326ec421cfc96
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY777da85a-a776-4681-976d-326ec421cfc96
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY777da85a-a776-4681-976d-326ec421cfc96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0853-000012108530010 TRAY in 1 CASE (0121-0853-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (0121-0853-20) 10 tray2018-08-290000-00-00NoNoCurrent
0121-0853-200012108532010 CUP, UNIT-DOSE in 1 TRAY (0121-0853-20) / 20 mL in 1 CUP, UNIT-DOSE2024-08-05NoNoCurrent
0121-0853-40001210853404 TRAY in 1 CASE (0121-0853-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (0121-0853-20) 4 tray2018-08-290000-00-00NoNoCurrent