FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
65862-496
11-digit product format
658620496
Labeler code
65862
Product ID
65862-496_49649c1f-a45f-446e-91ef-f1ebf9090363
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA091348
Marketing category
ANDA
Marketing start
2010-06-08
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
65862-496-01Sulfamethoxazole and Trimethoprim100 mL in 1 BOTTLESUSPENSION10017
65862-496-47Sulfamethoxazole and Trimethoprim473 mL in 1 BOTTLESUSPENSION47317
65862-496-50Sulfamethoxazole and Trimethoprim50 mL in 1 BOTTLESUSPENSION5017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-496-47ML - Milliliter65862-49625fa9958-f580-4395-a065-c4e86887f06812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
SORBITOLINACTIVE INGREDIENT506T60A25RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6
WATERINACTIVE INGREDIENT059QF0KO0RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-496SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 3 package rows20241206_a6182855-6287-45e9-b6b4-7b57efc9c76e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNa6182855-6287-45e9-b6b4-7b57efc9c76e17
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDa6182855-6287-45e9-b6b4-7b57efc9c76e17
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYa6182855-6287-45e9-b6b4-7b57efc9c76e17
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYa6182855-6287-45e9-b6b4-7b57efc9c76e17
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYa6182855-6287-45e9-b6b4-7b57efc9c76e17
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYa6182855-6287-45e9-b6b4-7b57efc9c76e17
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY69af86b4-9c9f-4a70-b448-97b36698f3cd16
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYacc3df02-1e99-46e6-8a31-9b26261c6daa7
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD4eb60cd1-612c-20ab-e054-00144ff88e886
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY4eb60cd1-612c-20ab-e054-00144ff88e886
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYf14b8d07-e73b-4ceb-bd6a-578c961b7c093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-496-0165862049601100 mL in 1 BOTTLE (65862-496-01) 100 ml2010-06-080000-00-00NoNoCurrent
65862-496-4765862049647473 mL in 1 BOTTLE (65862-496-47) 473 ml2010-06-080000-00-00NoNoCurrent
65862-496-506586204965050 mL in 1 BOTTLE (65862-496-50) 50 ml2010-06-080000-00-00NoNoCurrent