FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
65862-419
11-digit product format
658620419
Labeler code
65862
Product ID
65862-419_e4ea8e99-58d4-4c1b-b84c-db0838610059
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
400; 80 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
SULFAMETHOXAZOLE400 mg/1
TRIMETHOPRIM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui198334, 198335

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-419-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10017
65862-419-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET50017
65862-419-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET2017
65862-419-99Sulfamethoxazole and Trimethoprim1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-419-01EA - Each65862-4192de6c52c-d852-4951-b6fb-e7de58458ec012012-07-24
65862-419-05EA - Each65862-419321adcf1-dce5-46cb-aab9-5788bd8d48fe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]8
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-419SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AUROBINDO PHARMA LIMITED]17Current NDC, Legacy NDC, 4 package rows20250317_284b5dac-2b8d-46bf-95fe-80ce03fa178a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198334SMX 400 MG / TMP 80 MG Oral TabletSY284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335SMX 800 MG / TMP 160 MG Oral TabletSY284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198334SMX 400 MG / TMP 80 MG Oral TabletSY29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335SMX 800 MG / TMP 160 MG Oral TabletSY29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN7f25bff3-0e86-4bec-b293-54b68347867f6
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7f25bff3-0e86-4bec-b293-54b68347867f6
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD7f25bff3-0e86-4bec-b293-54b68347867f6
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD7f25bff3-0e86-4bec-b293-54b68347867f6
198334SMX 400 MG / TMP 80 MG Oral TabletSY7f25bff3-0e86-4bec-b293-54b68347867f6
198335SMX 800 MG / TMP 160 MG Oral TabletSY7f25bff3-0e86-4bec-b293-54b68347867f6
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN2d510d20-dd62-4b7a-b925-a3b71256a0494
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD2d510d20-dd62-4b7a-b925-a3b71256a0494
198334SMX 400 MG / TMP 80 MG Oral TabletSY2d510d20-dd62-4b7a-b925-a3b71256a0494
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN32e2b197-e171-444d-86ca-198d4c84d7a52
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN5c51042b-892c-f688-e053-2a91aa0a44d92
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN32e2b197-e171-444d-86ca-198d4c84d7a52
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD32e2b197-e171-444d-86ca-198d4c84d7a52
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD5c51042b-892c-f688-e053-2a91aa0a44d92
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD32e2b197-e171-444d-86ca-198d4c84d7a52
198334SMX 400 MG / TMP 80 MG Oral TabletSY32e2b197-e171-444d-86ca-198d4c84d7a52
198334SMX 400 MG / TMP 80 MG Oral TabletSY5c51042b-892c-f688-e053-2a91aa0a44d92
198335SMX 800 MG / TMP 160 MG Oral TabletSY32e2b197-e171-444d-86ca-198d4c84d7a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-419-0165862041901100 TABLET in 1 BOTTLE (65862-419-01) 100 tablet2010-02-160000-00-00NoNoCurrent
65862-419-0565862041905500 TABLET in 1 BOTTLE (65862-419-05) 500 tablet2010-02-160000-00-00NoNoCurrent
65862-419-206586204192020 TABLET in 1 BOTTLE (65862-419-20) 20 tablet2010-02-160000-00-00NoNoCurrent
65862-419-99658620419991000 TABLET in 1 BOTTLE (65862-419-99) 1000 tablet2010-02-160000-00-00NoNoCurrent