FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
53489-145
11-digit product format
534890145
Labeler code
53489
Product ID
53489-145_31dd7abe-e7f2-10df-e063-6394a90a93e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA071017
Marketing category
ANDA
Marketing start
1986-08-25
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
53489-145-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLE, PLASTICTABLET10019
53489-145-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLE, PLASTICTABLET50019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-145-01EA - Each53489-1458dd0e110-7c5a-4df0-a4c4-c009d8e93ab212012-07-24
53489-145-05EA - Each53489-1459af25ad6-a669-4a99-92c5-3f2b2864c64f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
SulfamethoxazoleACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
TrimethoprimACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
Docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]8
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SulfamethoxazoleACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TrimethoprimACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
Docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-145SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]19Current NDC, Legacy NDC, 2 package rows20250406_4833319a-a7b3-4bf4-bec4-6531b43182d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN4833319a-a7b3-4bf4-bec4-6531b43182d419
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN4833319a-a7b3-4bf4-bec4-6531b43182d419
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD4833319a-a7b3-4bf4-bec4-6531b43182d419
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD4833319a-a7b3-4bf4-bec4-6531b43182d419
198334SMX 400 MG / TMP 80 MG Oral TabletSY4833319a-a7b3-4bf4-bec4-6531b43182d419
198335SMX 800 MG / TMP 160 MG Oral TabletSY4833319a-a7b3-4bf4-bec4-6531b43182d419
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNbd3161fe-23d7-458a-86a4-fb958d9c94d312
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNbd3161fe-23d7-458a-86a4-fb958d9c94d312
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDbd3161fe-23d7-458a-86a4-fb958d9c94d312
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDbd3161fe-23d7-458a-86a4-fb958d9c94d312
198334SMX 400 MG / TMP 80 MG Oral TabletSYbd3161fe-23d7-458a-86a4-fb958d9c94d312
198335SMX 800 MG / TMP 160 MG Oral TabletSYbd3161fe-23d7-458a-86a4-fb958d9c94d312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-145-0153489014501100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01) 100 tablet1986-08-250000-00-00NoNoCurrent
53489-145-0553489014505500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05) 500 tablet1986-08-250000-00-00NoNoCurrent