FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
17856-0823
11-digit product format
178560823
Labeler code
17856
Product ID
17856-0823_cdb0a5e4-0aa9-4dee-b908-b20f6f9c7223
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Atlantic Biologicals Corps
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
No
Listing certified through
2020-12-31
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
17856-0823-12021-01-29C16284748780-1ba0f9c33-5123-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP
17856-0823-22021-01-29C16284748780-1ba0f9c33-5123-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP
17856-0823-32021-01-29C16284748780-1ba0f9c33-5123-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP
17856-0823-52021-01-29C16284748780-1ba0f9c33-5123-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Oral Suspension, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0823-1Sulfamethoxazole and Trimethoprim10 mL in 1 CUPSUSPENSION106
17856-0823-2Sulfamethoxazole and Trimethoprim20 mL in 1 CUPSUSPENSION206
17856-0823-3Sulfamethoxazole and Trimethoprim10 mL in 1 CUPSUSPENSION106
17856-0823-5Sulfamethoxazole and Trimethoprim5 mL in 1 CUPSUSPENSION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0823-2ML - Milliliter17856-0823748a0c51-2af3-4a75-ba73-394679a0b3e412013-08-02
17856-0823-5ML - Milliliter17856-0823bd23f93b-33f1-458a-8065-a67037fdb56412013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
CHERRYINACTIVE INGREDIENTBUC5I9595WSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
SORBITOLINACTIVE INGREDIENT506T60A25RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0823SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORPS]6Legacy NDC, 4 package rows20190921_c9676c8a-4597-4dcf-8944-18ecc96004e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNc9676c8a-4597-4dcf-8944-18ecc96004e26
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDc9676c8a-4597-4dcf-8944-18ecc96004e26
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYc9676c8a-4597-4dcf-8944-18ecc96004e26
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYc9676c8a-4597-4dcf-8944-18ecc96004e26
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYc9676c8a-4597-4dcf-8944-18ecc96004e26
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYc9676c8a-4597-4dcf-8944-18ecc96004e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0823-11785608230110 mL in 1 CUP10 mlHistorical
17856-0823-21785608230220 mL in 1 CUP20 mlHistorical
17856-0823-31785608230310 mL in 1 CUP10 mlHistorical
17856-0823-5178560823055 mL in 1 CUP5 mlHistorical