Sulfamethoxazole and Trimethoprim

Product NDC
53808-0798
11-digit product format
538080798
Labeler code
53808
Product ID
53808-0798_af332a04-0159-48e0-a069-f30c617181c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA076899
Marketing category
ANDA
Marketing start
2009-07-01
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
E
Listing certified through
2018-12-31
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
53808-0798-12020-01-31C16284748780-19d75b9d0-b4d3-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0798-1Sulfamethoxazole and Trimethoprim30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0798SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100824_dc9e3ad3-9599-420a-9697-95bb5a452652.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNdc9e3ad3-9599-420a-9697-95bb5a4526521
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDdc9e3ad3-9599-420a-9697-95bb5a4526521
198335SMX 800 MG / TMP 160 MG Oral TabletSYdc9e3ad3-9599-420a-9697-95bb5a4526521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0798-15380807980130 in 1 BLISTER PACKHistorical