FDA.reportPublic FDA data

SULFAMETHOXAZOLE and TRIMETHOPRIM

Product NDC
12634-779
11-digit product format
126340779
Labeler code
12634
Product ID
12634-779_51ea5805-beef-4741-a63e-76bf0fe03153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFAMETHOXAZOLE and TRIMETHOPRIM
Dosage form
SUSPENSION
Route
ORAL
Labeler
Apotheca, Inc.
Application
ANDA074650
Marketing category
ANDA
Marketing start
2009-11-03
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200 mg/5mL; mg/5mL
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
2018-12-31
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
12634-779-022020-01-31C16284748780-19d75b9cf-ff8c-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 200MG/40MG PER 5ML CHERRY Rx Only
12634-779-042020-01-31C16284748780-19d75b9cf-ff8c-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 200MG/40MG PER 5ML CHERRY Rx Only
12634-779-062020-01-31C16284748780-19d75b9cf-ff8c-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 200MG/40MG PER 5ML CHERRY Rx Only
12634-779-082020-01-31C16284748780-19d75b9cf-ff8c-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 200MG/40MG PER 5ML CHERRY Rx Only
12634-779-112020-01-31C16284748780-19d75b9cf-ff8c-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 200MG/40MG PER 5ML CHERRY Rx Only
12634-779-192020-01-31C16284748780-19d75b9cf-ff8c-f424-e053-dadaa90a57ceSULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 200MG/40MG PER 5ML CHERRY Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-779-02SULFAMETHOXAZOLE and TRIMETHOPRIM60 mL in 1 BOTTLESUSPENSION601
12634-779-04SULFAMETHOXAZOLE and TRIMETHOPRIM120 mL in 1 BOTTLESUSPENSION1201
12634-779-06SULFAMETHOXAZOLE and TRIMETHOPRIM180 mL in 1 BOTTLESUSPENSION1801
12634-779-08SULFAMETHOXAZOLE and TRIMETHOPRIM240 mL in 1 BOTTLESUSPENSION2401
12634-779-11SULFAMETHOXAZOLE and TRIMETHOPRIM100 mL in 1 BOTTLESUSPENSION1001
12634-779-19SULFAMETHOXAZOLE and TRIMETHOPRIM200 mL in 1 BOTTLESUSPENSION2001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
CHERRYINACTIVE INGREDIENTBUC5I9595WSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-779SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.]1Legacy NDC, 6 package rows20100428_fea44910-400c-4688-bedc-bbb1615cd8f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNfea44910-400c-4688-bedc-bbb1615cd8f51
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDfea44910-400c-4688-bedc-bbb1615cd8f51
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYfea44910-400c-4688-bedc-bbb1615cd8f51
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYfea44910-400c-4688-bedc-bbb1615cd8f51
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYfea44910-400c-4688-bedc-bbb1615cd8f51
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYfea44910-400c-4688-bedc-bbb1615cd8f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
12634-779-021263407790260 mL in 1 BOTTLE60 mlHistorical
12634-779-0412634077904120 mL in 1 BOTTLE120 mlHistorical
12634-779-0612634077906180 mL in 1 BOTTLE180 mlHistorical
12634-779-0812634077908240 mL in 1 BOTTLE240 mlHistorical
12634-779-1112634077911100 mL in 1 BOTTLE100 mlHistorical
12634-779-1912634077919200 mL in 1 BOTTLE200 mlHistorical