FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50090-6901
11-digit product format
500906901
Labeler code
50090
Product ID
50090-6901_1ce9fb0c-6acd-4205-8747-528c5339ba19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-09-13
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
Rxcui198335

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
50090-6901-0Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET101
50090-6901-1Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET141
50090-6901-2Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET201
50090-6901-3Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET281
50090-6901-5Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1001
50090-6901-7Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6901-1EA - Each50090-69014a2fb911-a7ea-463b-8d45-2a5fbafddbfd12024-01-04
50090-6901-2EA - Each50090-690146289503-b349-44af-a91d-594666e4bbbc12024-01-04
50090-6901-7EA - Each50090-690126ccac45-53cb-4287-962f-80ab0e3a10a712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6901SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 6 package rows20231216_07da67b1-b50c-4471-8cde-8a119eb8c935.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN07da67b1-b50c-4471-8cde-8a119eb8c9351
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD07da67b1-b50c-4471-8cde-8a119eb8c9351
198335SMX 800 MG / TMP 160 MG Oral TabletSY07da67b1-b50c-4471-8cde-8a119eb8c9351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6901-05009069010010 TABLET in 1 BOTTLE (50090-6901-0) 10 tablet2023-12-12NoNoHistorical
50090-6901-15009069010114 TABLET in 1 BOTTLE (50090-6901-1) 14 tablet2023-12-12NoNoHistorical
50090-6901-25009069010220 TABLET in 1 BOTTLE (50090-6901-2) 20 tablet2023-12-12NoNoHistorical
50090-6901-35009069010328 TABLET in 1 BOTTLE (50090-6901-3) 28 tablet2023-12-12NoNoHistorical
50090-6901-550090690105100 TABLET in 1 BOTTLE (50090-6901-5) 100 tablet2023-12-12NoNoHistorical
50090-6901-7500906901076 TABLET in 1 BOTTLE (50090-6901-7) 6 tablet2023-12-12NoNoHistorical