FDA.reportPublic FDA data

SULFATRIM

Product NDC
0121-0854
11-digit product format
001210854
Labeler code
0121
Product ID
0121-0854_a13ce54e-96e8-437a-b4f7-0af852a5a10a
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
1983-07-03
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
SULFATRIM
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
Rxcui208406, 313134

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-0854-162021-02-15C16284748780-1ba0f9c33-5af0-a910-e053-dadaa90a0b85SULFATRIM™ - Pediatric Suspension SULFATRIM™ - sulfamethoxazole and trimethoprim suspension Pharmaceutical Associates, Inc.
0121-0854-162021-01-29C16284748780-1ba0f9c33-5af0-a910-e053-dadaa90a0b85SULFATRIM™ - Pediatric Suspension SULFATRIM™ - sulfamethoxazole and trimethoprim suspension Pharmaceutical Associates, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0854-16SULFATRIM473 mL in 1 BOTTLESUSPENSION47312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0854-16ML - Milliliter0121-0854a2bf2ba7-c290-4e08-a8fe-2c4d0f2db8c612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0854SULFATRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]12Current NDC, Legacy NDC, 1 package rows20250309_c62086ea-ba15-40f5-8431-4639c60c9825.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNc62086ea-ba15-40f5-8431-4639c60c982512
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSNc62086ea-ba15-40f5-8431-4639c60c982512
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBDc62086ea-ba15-40f5-8431-4639c60c982512
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDc62086ea-ba15-40f5-8431-4639c60c982512
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYc62086ea-ba15-40f5-8431-4639c60c982512
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SYc62086ea-ba15-40f5-8431-4639c60c982512
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYc62086ea-ba15-40f5-8431-4639c60c982512
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYc62086ea-ba15-40f5-8431-4639c60c982512
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYc62086ea-ba15-40f5-8431-4639c60c982512
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSYc62086ea-ba15-40f5-8431-4639c60c982512
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNcd4932ce-0856-4e99-8baf-70afce1d7ffd6
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSNcd4932ce-0856-4e99-8baf-70afce1d7ffd6
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBDcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSYcd4932ce-0856-4e99-8baf-70afce1d7ffd6
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSNb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBDb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN80f7f00b-add4-4d6b-9e9c-bea29768c2392
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSN80f7f00b-add4-4d6b-9e9c-bea29768c2392
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBD80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SY80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSY80f7f00b-add4-4d6b-9e9c-bea29768c2392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0854-1600121085416473 mL in 1 BOTTLE (0121-0854-16) 473 ml1983-07-030000-00-00NoNoCurrent