FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50090-4430
11-digit product format
500904430
Labeler code
50090
Product ID
50090-4430_054c30c8-9585-4069-8923-f073ddf542da
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
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
2021-12-31
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
50090-4430-02023-01-30C16284748780-1f386c64a-2725-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
50090-4430-12023-01-30C16284748780-1f386c64a-2725-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4430-0Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET141
50090-4430-1Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4430SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20200710_f014606a-fb80-4e67-ac0a-168cda313d59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf014606a-fb80-4e67-ac0a-168cda313d591
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf014606a-fb80-4e67-ac0a-168cda313d591
198335SMX 800 MG / TMP 160 MG Oral TabletSYf014606a-fb80-4e67-ac0a-168cda313d591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4430-05009044300014 TABLET in 1 BOTTLE (50090-4430-0) 14 tablet2019-07-190000-00-00NoNoCurrent
50090-4430-15009044300114 TABLET in 1 BOTTLE (50090-4430-1) 14 tablet2019-07-190000-00-00NoNoCurrent