FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50268-729
11-digit product format
502680729
Labeler code
50268
Product ID
50268-729_71e9b4f8-4bde-1869-e053-2995a90a19c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA090624
Marketing category
ANDA
Marketing start
2014-09-23
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-729-11Sulfamethoxazole and Trimethoprim1 in 1 BLISTER PACKTABLET110
50268-729-13Sulfamethoxazole and Trimethoprim30 in 1 BOX, UNIT-DOSETABLET3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-729-11EA - Each50268-729b8548481-bae2-4484-95ab-ee57d37ae5e512015-03-03
50268-729-13EA - Each50268-7295a13b2ce-9940-4f82-bf2e-7d84f8eaee3112014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-729SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AVPAK]8Legacy NDC, 2 package rows20240110_29df8839-3dfa-0b2b-c5a3-906db6997b3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198334SMX 400 MG / TMP 80 MG Oral TabletSY29df8839-3dfa-0b2b-c5a3-906db6997b3b10
198335SMX 800 MG / TMP 160 MG Oral TabletSY29df8839-3dfa-0b2b-c5a3-906db6997b3b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50268-729-11502680729111 in 1 BLISTER PACKHistorical
50268-729-135026807291330 in 1 BOX, UNIT-DOSEHistorical