FDA.reportPublic FDA data

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product NDC
61919-766
11-digit product format
619190766
Labeler code
61919
Product ID
61919-766_b476f932-733b-4bde-bd42-afe553db3089
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA076817
Marketing category
ANDA
Marketing start
2015-01-01
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
E
Listing certified through
2017-12-31
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
61919-766-102020-01-31C16284748780-19d75b9d1-2a18-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM
61919-766-142020-01-31C16284748780-19d75b9d1-2a18-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM
61919-766-202020-01-31C16284748780-19d75b9d1-2a18-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-766-10SULFAMETHOXAZOLE AND TRIMETHOPRIM10 in 1 BOTTLETABLET103
61919-766-14SULFAMETHOXAZOLE AND TRIMETHOPRIM14 in 1 BOTTLETABLET143
61919-766-20SULFAMETHOXAZOLE AND TRIMETHOPRIM20 in 1 BOTTLETABLET203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-766-10EA - Each61919-7666976fe92-b436-44cf-b543-b96d26fa6afc12016-09-02
61919-766-14EA - Each61919-766ba4576d9-3500-4ac5-ace8-da7bc919b79212016-09-02
61919-766-20EA - Each61919-7667680e715-4df4-4c56-9128-be18178800cd12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-766SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3Legacy NDC, 3 package rows20151102_a0f86f52-8841-4e1c-8536-2e78320471ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNa0f86f52-8841-4e1c-8536-2e78320471ed3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDa0f86f52-8841-4e1c-8536-2e78320471ed3
198335SMX 800 MG / TMP 160 MG Oral TabletSYa0f86f52-8841-4e1c-8536-2e78320471ed3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-766-106191907661010 in 1 BOTTLEHistorical
61919-766-146191907661414 in 1 BOTTLEHistorical
61919-766-206191907662020 in 1 BOTTLEHistorical