FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50090-2890
11-digit product format
500902890
Labeler code
50090
Product ID
50090-2890_86a6cb1d-a20e-4320-94c5-6c2d483547e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071017
Marketing category
ANDA
Marketing start
1986-08-25
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
50090-2890-02020-01-31C16284748780-19d75b9d0-bb69-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP
50090-2890-12020-01-31C16284748780-19d75b9d0-bb69-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2890-0Sulfamethoxazole and Trimethoprim33 in 1 BOX, UNIT-DOSETABLET333
50090-2890-0Sulfamethoxazole and Trimethoprim1 in 1 BLISTER PACKTABLET13
50090-2890-1Sulfamethoxazole and Trimethoprim10 in 1 BLISTER PACKTABLET103
50090-2890-1Sulfamethoxazole and Trimethoprim10 in 1 BOX, UNIT-DOSETABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2890-0EA - Each50090-28905fb0f27e-32ee-47e9-95f0-d49d13776bbe12019-04-11
50090-2890-1EA - Each50090-28904847b3fe-80f6-4781-b8d9-b9d8fac4a83d12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2890SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 4 package rows20190225_d48ed3f0-d1dc-4548-95df-7786ce0f444a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNd48ed3f0-d1dc-4548-95df-7786ce0f444a3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDd48ed3f0-d1dc-4548-95df-7786ce0f444a3
198335SMX 800 MG / TMP 160 MG Oral TabletSYd48ed3f0-d1dc-4548-95df-7786ce0f444a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2890-05009028900033 in 1 BOX, UNIT-DOSEHistorical
50090-2890-15009028900110 in 1 BLISTER PACKHistorical