FDA.reportPublic FDA data

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product NDC
61919-210
11-digit product format
619190210
Labeler code
61919
Product ID
61919-210_d0286beb-809c-429d-aae2-f478f260cbfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA071017
Marketing category
ANDA
Marketing start
2014-01-01
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
61919-210-062020-01-31C16284748780-19d75b9d0-2203-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM
61919-210-142020-01-31C16284748780-19d75b9d0-2203-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM
61919-210-202020-01-31C16284748780-19d75b9d0-2203-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM
61919-210-282020-01-31C16284748780-19d75b9d0-2203-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM
61919-210-302020-01-31C16284748780-19d75b9d0-2203-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM
61919-210-602020-01-31C16284748780-19d75b9d0-2203-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-210-06SULFAMETHOXAZOLE AND TRIMETHOPRIM6 in 1 BOTTLETABLET63
61919-210-14SULFAMETHOXAZOLE AND TRIMETHOPRIM14 in 1 BOTTLETABLET143
61919-210-20SULFAMETHOXAZOLE AND TRIMETHOPRIM20 in 1 BOTTLETABLET203
61919-210-28SULFAMETHOXAZOLE AND TRIMETHOPRIM28 in 1 BOTTLETABLET283
61919-210-30SULFAMETHOXAZOLE AND TRIMETHOPRIM30 in 1 BOTTLETABLET303
61919-210-60SULFAMETHOXAZOLE AND TRIMETHOPRIM60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-210-20EA - Each61919-21054adbff5-bfd3-464e-bf09-63d7d90c727112015-03-03
61919-210-28EA - Each61919-2105017d520-cf02-468c-88c9-1115ec45d67a12015-03-03

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
Docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
magnesium stearateINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE 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
61919-210SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [DIRECT RX]3Legacy NDC, 6 package rows20151105_3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b23
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b23
198335SMX 800 MG / TMP 160 MG Oral TabletSY3fcdd0a5-23e1-49c5-b9a7-f2c000cad1b23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-210-06619190210066 in 1 BOTTLEHistorical
61919-210-146191902101414 in 1 BOTTLEHistorical
61919-210-206191902102020 in 1 BOTTLEHistorical
61919-210-286191902102828 in 1 BOTTLEHistorical
61919-210-306191902103030 in 1 BOTTLEHistorical
61919-210-606191902106060 in 1 BOTTLEHistorical