FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
60429-259
11-digit product format
604290259
Labeler code
60429
Product ID
60429-259_36efef59-2b05-db1b-e063-6394a90af8ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA071017
Marketing category
ANDA
Marketing start
1986-08-25
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
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
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-259-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLE, PLASTICTABLET10012
60429-259-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLE, PLASTICTABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-259-01EA - Each60429-2595c801d09-7395-4f57-b0d5-10a39a65f45012015-09-10
60429-259-05EA - Each60429-259e118d726-b4df-47f7-a3c1-30f76453d57712015-09-10
60429-259-20EA - Each60429-259d378c1f0-fc46-46bb-b282-2a2a551e55e612015-09-10
60429-259-40EA - Each60429-25954bc3ffe-0dd0-4a2f-8aa8-c7c95fede97412015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
60429-259SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]11Current NDC, Legacy NDC, 2 package rows20241027_bd3161fe-23d7-458a-86a4-fb958d9c94d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
60429-259-0160429025901100 TABLET in 1 BOTTLE, PLASTIC (60429-259-01) 100 tablet2015-04-240000-00-00NoNoCurrent
60429-259-0560429025905500 TABLET in 1 BOTTLE, PLASTIC (60429-259-05) 500 tablet2015-04-240000-00-00NoNoCurrent