FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
52959-766
11-digit product format
529590766
Labeler code
52959
Product ID
52959-766_1fc8d359-d5b3-42ac-82c4-cc0ebe609198
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA074650
Marketing category
ANDA
Marketing start
1997-12-29
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
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
52959-766-052019-11-13C16284748780-197449f38-d1a8-f6ea-e053-dbdaa90aa703Sulfamethoxazole and Trimethoprim Oral Suspension, USP
52959-766-072019-11-13C16284748780-197449f38-d1a8-f6ea-e053-dbdaa90aa703Sulfamethoxazole and Trimethoprim Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-766-05Sulfamethoxazole and Trimethoprim100 mL in 1 BOTTLESUSPENSION1001
52959-766-07Sulfamethoxazole and Trimethoprim118 mL in 1 BOTTLESUSPENSION1181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-766-05ML - Milliliter52959-766b968b970-8603-4e71-98cd-b0c6d18586a112012-07-24
52959-766-07ML - Milliliter52959-76621f8a5b8-5dea-4987-b633-9efe95f821b612012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-766SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 2 package rows20111205_c8833d0d-9e8e-40cf-b6df-d559ea83b7b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNc8833d0d-9e8e-40cf-b6df-d559ea83b7b21
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDc8833d0d-9e8e-40cf-b6df-d559ea83b7b21
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYc8833d0d-9e8e-40cf-b6df-d559ea83b7b21
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYc8833d0d-9e8e-40cf-b6df-d559ea83b7b21
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYc8833d0d-9e8e-40cf-b6df-d559ea83b7b21
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYc8833d0d-9e8e-40cf-b6df-d559ea83b7b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-766-0552959076605100 mL in 1 BOTTLE100 mlHistorical
52959-766-0752959076607118 mL in 1 BOTTLE118 mlHistorical