FDA.reportPublic FDA data

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product NDC
61919-144
11-digit product format
619190144
Labeler code
61919
Product ID
61919-144_9cad4b05-2b58-d662-e053-2995a90ad7fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090624
Marketing category
ANDA
Marketing start
2019-08-13
Marketing end
0000-00-00
Substance
TRIMETHOPRIM; SULFAMETHOXAZOLE
Active strength
160 mg/1; mg/1
Pharmacologic classes
Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA],Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 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
61919-144-302022-01-28C16284748780-1d6a99b39-8618-a426-e053-dadaa90af4c2SULFAMETH/TRIMETH DS
61919-144-062021-01-29C16284748780-1ba0f9c33-3261-a910-e053-dadaa90a0b85SULFAMETH/TRIMETH DS
61919-144-202020-01-31C16284748780-19d75b9d1-020d-f424-e053-dadaa90a57ceSULFAMETH/TRIMETH DS
61919-144-562020-01-31C16284748780-19d75b9d1-020d-f424-e053-dadaa90a57ceSULFAMETH/TRIMETH DS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-144-20SULFAMETHOXAZOLE AND TRIMETHOPRIM20 in 1 BOTTLETABLET202
61919-144-30SULFAMETHOXAZOLE AND TRIMETHOPRIM30 in 1 BOTTLETABLET302
61919-144-56SULFAMETHOXAZOLE AND TRIMETHOPRIM56 in 1 BOTTLETABLET562
61919-144-06SULFAMETHOXAZOLE AND TRIMETHOPRIM6 in 1 BOTTLETABLET61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-144-06EA - Each61919-144d0a4d718-0cb8-4e70-8a8a-d69dd775ac5512019-09-05
61919-144-20EA - Each61919-144a3d7397d-7360-4279-a934-9403a7c1b2d112019-04-11
61919-144-30EA - Each61919-144e6f62f97-511b-462d-8ab2-bcd6b406a2e112019-09-05
61919-144-56EA - Each61919-1440cd46a85-ebbe-43f7-947b-9b51444d0c3d12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-144SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]2Legacy NDC, 2 package rows20180615_5488e98e-3955-017c-e054-00144ff8d46c.zip
61919-144SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20200122_9003c06e-5d28-af7e-e053-2995a90ad432.zip
61919-144SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190814_9003519f-26d6-5d4c-e053-2995a90a429e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN5488e98e-3955-017c-e054-00144ff8d46c2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN9003c06e-5d28-af7e-e053-2995a90ad4322
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD5488e98e-3955-017c-e054-00144ff8d46c2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD9003c06e-5d28-af7e-e053-2995a90ad4322
198335SMX 800 MG / TMP 160 MG Oral TabletSY5488e98e-3955-017c-e054-00144ff8d46c2
198335SMX 800 MG / TMP 160 MG Oral TabletSY9003c06e-5d28-af7e-e053-2995a90ad4322
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN9003519f-26d6-5d4c-e053-2995a90a429e1
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD9003519f-26d6-5d4c-e053-2995a90a429e1
198335SMX 800 MG / TMP 160 MG Oral TabletSY9003519f-26d6-5d4c-e053-2995a90a429e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-144-06619190144066 in 1 BOTTLEHistorical
61919-144-206191901442020 in 1 BOTTLEHistorical
61919-144-306191901443030 TABLET in 1 BOTTLE (61919-144-30) 30 tablet2019-08-130000-00-00NoNoCurrent
61919-144-566191901445656 in 1 BOTTLEHistorical