FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
65862-420
11-digit product format
658620420
Labeler code
65862
Product ID
65862-420_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
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
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
SULFAMETHOXAZOLE800 mg/1
TRIMETHOPRIM160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAN164J8Y0X, JE42381TNV
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
65862-420-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10017
65862-420-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET50017
65862-420-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET2017
65862-420-99Sulfamethoxazole and Trimethoprim1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-420-01EA - Each65862-4200441fe3e-5d24-45d9-ae2d-298fb09d776d12012-07-24
65862-420-05EA - Each65862-4200c7bac96-66bb-484f-8713-af5e0a07506812012-07-24

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 (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]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 [AVPAK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-420SULFAMETHOXAZOLE 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
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3ef62512-0dc3-4821-9b60-6b375841c4c026
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3ef62512-0dc3-4821-9b60-6b375841c4c026
198335SMX 800 MG / TMP 160 MG Oral TabletSY3ef62512-0dc3-4821-9b60-6b375841c4c026
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN99e1ace6-7665-4f87-82fd-5e7c4989e09821
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN62616708-a538-459f-9b7f-ed90c6aa5fc621
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD99e1ace6-7665-4f87-82fd-5e7c4989e09821
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD62616708-a538-459f-9b7f-ed90c6aa5fc621
198335SMX 800 MG / TMP 160 MG Oral TabletSY99e1ace6-7665-4f87-82fd-5e7c4989e09821
198335SMX 800 MG / TMP 160 MG Oral TabletSY62616708-a538-459f-9b7f-ed90c6aa5fc621
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNc4da9c4f-0704-4ed5-9d19-5c949f37f72620
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDc4da9c4f-0704-4ed5-9d19-5c949f37f72620
198335SMX 800 MG / TMP 160 MG Oral TabletSYc4da9c4f-0704-4ed5-9d19-5c949f37f72620
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNfd90d8bd-1b84-4347-a98a-f8f94746f3e419
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDfd90d8bd-1b84-4347-a98a-f8f94746f3e419
198335SMX 800 MG / TMP 160 MG Oral TabletSYfd90d8bd-1b84-4347-a98a-f8f94746f3e419
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNd8239804-d234-491b-965d-89a7796a5e4d17
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDd8239804-d234-491b-965d-89a7796a5e4d17
198334SMX 400 MG / TMP 80 MG Oral TabletSY284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335SMX 800 MG / TMP 160 MG Oral TabletSY284b5dac-2b8d-46bf-95fe-80ce03fa178a17
198335SMX 800 MG / TMP 160 MG Oral TabletSYd8239804-d234-491b-965d-89a7796a5e4d17
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN14767ff8-7803-4922-ac03-ff80c061e5ba16
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNc2307cc2-43ee-4319-ad58-d1d28a95e5aa16
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDc2307cc2-43ee-4319-ad58-d1d28a95e5aa16
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD14767ff8-7803-4922-ac03-ff80c061e5ba16
198335SMX 800 MG / TMP 160 MG Oral TabletSY14767ff8-7803-4922-ac03-ff80c061e5ba16
198335SMX 800 MG / TMP 160 MG Oral TabletSYc2307cc2-43ee-4319-ad58-d1d28a95e5aa16
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN4e12b7e1-fa2f-4cd1-ada6-19a7d565234815
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD4e12b7e1-fa2f-4cd1-ada6-19a7d565234815
198335SMX 800 MG / TMP 160 MG Oral TabletSY4e12b7e1-fa2f-4cd1-ada6-19a7d565234815
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
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN41529314-b203-47f4-88dd-5aa57c74985f7
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD41529314-b203-47f4-88dd-5aa57c74985f7
198335SMX 800 MG / TMP 160 MG Oral TabletSY41529314-b203-47f4-88dd-5aa57c74985f7
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
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNb000150f-3be6-2e6c-e053-2995a90a67d55
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN29e83667-8d4a-49b7-9182-653cbfb2dee75
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNa56a7056-c72a-4e25-9c41-327f429e7af05
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDa56a7056-c72a-4e25-9c41-327f429e7af05
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD29e83667-8d4a-49b7-9182-653cbfb2dee75
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDb000150f-3be6-2e6c-e053-2995a90a67d55
198335SMX 800 MG / TMP 160 MG Oral TabletSYb000150f-3be6-2e6c-e053-2995a90a67d55
198335SMX 800 MG / TMP 160 MG Oral TabletSYa56a7056-c72a-4e25-9c41-327f429e7af05
198335SMX 800 MG / TMP 160 MG Oral TabletSY29e83667-8d4a-49b7-9182-653cbfb2dee75
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN56de2d42-5cb5-4634-a1f8-f1c8397b02ed4
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf7f97520-d063-ec87-e053-6294a90aae0c4
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN46dc8f62-e700-50e3-e054-00144ff8d46c4
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD46dc8f62-e700-50e3-e054-00144ff8d46c4
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD56de2d42-5cb5-4634-a1f8-f1c8397b02ed4
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf7f97520-d063-ec87-e053-6294a90aae0c4
198335SMX 800 MG / TMP 160 MG Oral TabletSY56de2d42-5cb5-4634-a1f8-f1c8397b02ed4
198335SMX 800 MG / TMP 160 MG Oral TabletSY46dc8f62-e700-50e3-e054-00144ff8d46c4
198335SMX 800 MG / TMP 160 MG Oral TabletSYf7f97520-d063-ec87-e053-6294a90aae0c4
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN505ee941-2962-35e4-e054-00144ff88e883
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3ed6bf70-2841-04f8-e054-00144ff8d46c3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD505ee941-2962-35e4-e054-00144ff88e883
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3ed6bf70-2841-04f8-e054-00144ff8d46c3
198335SMX 800 MG / TMP 160 MG Oral TabletSY505ee941-2962-35e4-e054-00144ff88e883
198335SMX 800 MG / TMP 160 MG Oral TabletSY3ed6bf70-2841-04f8-e054-00144ff8d46c3
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN32e2b197-e171-444d-86ca-198d4c84d7a52
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN5488e98e-3955-017c-e054-00144ff8d46c2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN9003c06e-5d28-af7e-e053-2995a90ad4322
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN32e2b197-e171-444d-86ca-198d4c84d7a52
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD32e2b197-e171-444d-86ca-198d4c84d7a52
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD9003c06e-5d28-af7e-e053-2995a90ad4322
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD32e2b197-e171-444d-86ca-198d4c84d7a52
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD5488e98e-3955-017c-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-420-0165862042001100 TABLET in 1 BOTTLE (65862-420-01) 100 tablet2010-02-160000-00-00NoNoCurrent
65862-420-0565862042005500 TABLET in 1 BOTTLE (65862-420-05) 500 tablet2010-02-160000-00-00NoNoCurrent
65862-420-206586204202020 TABLET in 1 BOTTLE (65862-420-20) 20 tablet2010-02-160000-00-00NoNoCurrent
65862-420-99658620420991000 TABLET in 1 BOTTLE (65862-420-99) 1000 tablet2010-02-160000-00-00NoNoCurrent