Sulfamethoxazole and Trimethoprim

Product NDC
53808-0981
11-digit product format
538080981
Labeler code
53808
Product ID
53808-0981_e3305dd9-e369-4db8-9274-f94fca384ea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA090828
Marketing category
ANDA
Marketing start
2013-01-01
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
53808-0981-12020-01-31C16284748780-19d75b9d0-7b79-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (Double Strength) and 400 mg/80 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0981-1Sulfamethoxazole and Trimethoprim30 in 1 BLISTER PACKTABLET302

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0981SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20140428_3add3659-fd33-4e5d-ad9b-8486aa10220d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3add3659-fd33-4e5d-ad9b-8486aa10220d2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3add3659-fd33-4e5d-ad9b-8486aa10220d2
198335SMX 800 MG / TMP 160 MG Oral TabletSY3add3659-fd33-4e5d-ad9b-8486aa10220d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0981-15380809810130 in 1 BLISTER PACKHistorical