FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50436-4693
11-digit product format
504364693
Labeler code
50436
Product ID
50436-4693_c6c40273-01a9-4b32-b543-cea43a1f8012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-09-13
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
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
50436-4693-12021-01-29C16284748780-1ba0f9c33-4fdc-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
50436-4693-22021-01-29C16284748780-1ba0f9c33-4fdc-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
50436-4693-32021-01-29C16284748780-1ba0f9c33-4fdc-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
50436-4693-42021-01-29C16284748780-1ba0f9c33-4fdc-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only
50436-4693-62021-01-29C16284748780-1ba0f9c33-4fdc-a910-e053-dadaa90a0b85Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4693-1Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET286
50436-4693-2Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET206
50436-4693-3Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET306
50436-4693-4Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET146
50436-4693-6Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4693-1EA - Each50436-469303debe05-e65e-4f4d-a5b2-2f7e34f35f5a12014-12-01
50436-4693-2EA - Each50436-46936d15879b-a3ca-45ff-b444-cfef1f7518d812014-12-01
50436-4693-3EA - Each50436-469373083c26-54d9-467b-859c-a13815285fd112015-10-02
50436-4693-4EA - Each50436-469355856d9e-8797-4e14-bd4c-7e280d72aa5e12014-12-01
50436-4693-6EA - Each50436-469380322179-0930-4311-9b64-7644c89628c612014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4693SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [UNIT DOSE SERVICES]6Legacy NDC, 5 package rows20190531_09086798-2dc3-4a0d-a02a-304baec56b72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN09086798-2dc3-4a0d-a02a-304baec56b726
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD09086798-2dc3-4a0d-a02a-304baec56b726
198335SMX 800 MG / TMP 160 MG Oral TabletSY09086798-2dc3-4a0d-a02a-304baec56b726

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4693-15043646930128 in 1 BOTTLEHistorical
50436-4693-25043646930220 in 1 BOTTLEHistorical
50436-4693-35043646930330 in 1 BOTTLEHistorical
50436-4693-45043646930414 in 1 BOTTLEHistorical
50436-4693-65043646930610 in 1 BOTTLEHistorical