FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50090-5679
11-digit product format
500905679
Labeler code
50090
Product ID
50090-5679_10df7d9e-53c6-429e-9cf2-caa44bfaeb9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5679-02023-02-07C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-12023-02-07C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-22023-02-07C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-32023-02-07C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-52023-02-07C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-72023-02-07C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-02023-01-30C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-12023-01-30C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-22023-01-30C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-32023-01-30C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-52023-01-30C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-5679-72023-01-30C16284748780-1f386c649-eead-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5679-0Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET105
50090-5679-1Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET145
50090-5679-2Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET205
50090-5679-3Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET285
50090-5679-5Sulfamethoxazole and Trimethoprim100 in 1 BOTTLETABLET1005
50090-5679-7Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5679-0EA - Each50090-567943519eee-95cb-441e-8703-55842a1878b012022-10-06
50090-5679-1EA - Each50090-5679724788c3-4b2f-4d10-b928-5c8335cbd23012022-12-07
50090-5679-2EA - Each50090-56797c2ef1f4-aa32-487c-8a6f-3793a01f563512022-12-07
50090-5679-3EA - Each50090-5679e40f0f26-89fb-44f2-b2e4-cd22b0aefbe212022-12-07
50090-5679-5EA - Each50090-56794baad61b-f79b-4fd6-a22f-b40c52077bd412022-10-06
50090-5679-7EA - Each50090-5679293894b5-42dd-4d92-82b8-3f2ec1b7c13012022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5679SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 6 package rows20250227_8c74ea5c-d05e-4fc1-b980-aacaab56d472.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN8c74ea5c-d05e-4fc1-b980-aacaab56d4725
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD8c74ea5c-d05e-4fc1-b980-aacaab56d4725
198335SMX 800 MG / TMP 160 MG Oral TabletSY8c74ea5c-d05e-4fc1-b980-aacaab56d4725

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5679-05009056790010 TABLET in 1 BOTTLE (50090-5679-0) 10 tablet2021-09-210000-00-00NoNoCurrent
50090-5679-15009056790114 TABLET in 1 BOTTLE (50090-5679-1) 14 tablet2021-09-210000-00-00NoNoCurrent
50090-5679-25009056790220 TABLET in 1 BOTTLE (50090-5679-2) 20 tablet2021-09-210000-00-00NoNoCurrent
50090-5679-35009056790328 TABLET in 1 BOTTLE (50090-5679-3) 28 tablet2021-09-210000-00-00NoNoCurrent
50090-5679-550090567905100 TABLET in 1 BOTTLE (50090-5679-5) 100 tablet2021-09-210000-00-00NoNoCurrent
50090-5679-7500905679076 TABLET in 1 BOTTLE (50090-5679-7) 6 tablet2021-09-210000-00-00NoNoCurrent