FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
61971-120
11-digit product format
619710120
Labeler code
61971
Product ID
61971-120_69d5e1fe-d9e9-4afa-bd62-8df032a34d32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Vista Pharmaceuticals, Inc.
Application
ANDA076817
Marketing category
ANDA
Marketing start
2006-08-22
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
61971-120-01Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1008
61971-120-05Sulfamethoxazole and Trimethoprim500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61971-120-01EA - Each61971-120946e35d0-3b29-490b-b09e-93ec6a22722712013-02-13
61971-120-05EA - Each61971-1201c110c15-5ba0-4c8d-98d1-753d392a40fd12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]7
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]7
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]7
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]7
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]5
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]5
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]5
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]5
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [VISTA PHARMACEUTICALS, INC.]5
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61971-120SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [VISTA PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20200123_3edca473-8fdc-462a-b378-6c3279503a70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN3edca473-8fdc-462a-b378-6c3279503a708
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3edca473-8fdc-462a-b378-6c3279503a708
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNc407381f-3d8e-4fdf-9132-cd39680992968
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD3edca473-8fdc-462a-b378-6c3279503a708
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDc407381f-3d8e-4fdf-9132-cd39680992968
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3edca473-8fdc-462a-b378-6c3279503a708
198334SMX 400 MG / TMP 80 MG Oral TabletSY3edca473-8fdc-462a-b378-6c3279503a708
198335SMX 800 MG / TMP 160 MG Oral TabletSYc407381f-3d8e-4fdf-9132-cd39680992968
198335SMX 800 MG / TMP 160 MG Oral TabletSY3edca473-8fdc-462a-b378-6c3279503a708
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN17c7ace2-6f06-4111-e054-00144ff88e887
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD17c7ace2-6f06-4111-e054-00144ff88e887
198335SMX 800 MG / TMP 160 MG Oral TabletSY17c7ace2-6f06-4111-e054-00144ff88e887
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN4180c1d6-1aac-470e-e054-00144ff88e884
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD4180c1d6-1aac-470e-e054-00144ff88e884
198335SMX 800 MG / TMP 160 MG Oral TabletSY4180c1d6-1aac-470e-e054-00144ff88e884
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNa0f86f52-8841-4e1c-8536-2e78320471ed3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDa0f86f52-8841-4e1c-8536-2e78320471ed3
198335SMX 800 MG / TMP 160 MG Oral TabletSYa0f86f52-8841-4e1c-8536-2e78320471ed3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61971-120-0161971012001100 TABLET in 1 BOTTLE (61971-120-01) 100 tablet2006-08-220000-00-00NoNoCurrent
61971-120-0561971012005500 TABLET in 1 BOTTLE (61971-120-05) 500 tablet2006-08-220000-00-00NoNoCurrent