FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
53746-271
11-digit product format
537460271
Labeler code
53746
Product ID
53746-271_bc5fe496-071b-4c25-95da-14c6c561e79e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-02-25
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
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
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-271-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET10019
53746-271-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET50019
53746-271-10Sulfamethoxazole and Trimethoprim1000 in 1 BOTTLETABLET100019
53746-271-50Sulfamethoxazole and Trimethoprim50 in 1 BOTTLETABLET5019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-271-01EA - Each53746-2714c3013c0-5ee6-4057-8a4a-c7d9cd8d8f4212012-07-24
53746-271-05EA - Each53746-27145dcf3ff-6233-4236-b493-7c2d6898cd1412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS, LLC]8
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-271SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]19Current NDC, Legacy NDC, 4 package rows20250321_3233c54d-484d-4550-b172-db8af47d1b7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN3233c54d-484d-4550-b172-db8af47d1b7f19
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3233c54d-484d-4550-b172-db8af47d1b7f19
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD3233c54d-484d-4550-b172-db8af47d1b7f19
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3233c54d-484d-4550-b172-db8af47d1b7f19
198334SMX 400 MG / TMP 80 MG Oral TabletSY3233c54d-484d-4550-b172-db8af47d1b7f19
198335SMX 800 MG / TMP 160 MG Oral TabletSY3233c54d-484d-4550-b172-db8af47d1b7f19
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN9f130443-c8e7-9122-8f27-f72f07f3f29e12
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD9f130443-c8e7-9122-8f27-f72f07f3f29e12
198334SMX 400 MG / TMP 80 MG Oral TabletSY9f130443-c8e7-9122-8f27-f72f07f3f29e12
198335SMX 800 MG / TMP 160 MG Oral TabletSY9f130443-c8e7-9122-8f27-f72f07f3f29e12
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN407fe0e4-f1e9-4876-e054-00144ff88e884
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD407fe0e4-f1e9-4876-e054-00144ff88e884
198334SMX 400 MG / TMP 80 MG Oral TabletSY407fe0e4-f1e9-4876-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-271-0153746027101100 TABLET in 1 BOTTLE (53746-271-01) 100 tablet2010-02-250000-00-00NoNoCurrent
53746-271-0553746027105500 TABLET in 1 BOTTLE (53746-271-05) 500 tablet2010-02-250000-00-00NoNoCurrent
53746-271-10537460271101000 TABLET in 1 BOTTLE (53746-271-10) 1000 tablet2010-02-250000-00-00NoNoCurrent
53746-271-505374602715050 TABLET in 1 BOTTLE (53746-271-50) 50 tablet2010-02-250000-00-00NoNoCurrent