SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product NDC
58517-140
11-digit product format
585170140
Labeler code
58517
Product ID
58517-140_c3e59ee7-b196-4088-8662-2f047c6e1216
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Dosage form
TABLET
Route
ORAL
Labeler
New Horizon Rx Group, LLC
Application
ANDA076899
Marketing category
ANDA
Marketing start
2013-08-25
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
58517-140-202020-01-31C16284748780-19d75b9d0-75ca-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58517-140-20SULFAMETHOXAZOLE AND TRIMETHOPRIMdouble strength20 in 1 BOTTLETABLET204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58517-140-20EA - Each58517-140f3f7e17f-856f-468e-b4e6-433dc4c8627112013-10-17

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58517-140SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [NEW HORIZON RX GROUP, LLC]4Legacy NDC, 1 package rows20131231_804f8363-8ea1-4a57-bbd1-7fd9b6b4d29b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN804f8363-8ea1-4a57-bbd1-7fd9b6b4d29b4
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD804f8363-8ea1-4a57-bbd1-7fd9b6b4d29b4
198335SMX 800 MG / TMP 160 MG Oral TabletSY804f8363-8ea1-4a57-bbd1-7fd9b6b4d29b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58517-140-205851701402020 in 1 BOTTLEHistorical