FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
50383-824
11-digit product format
503830824
Labeler code
50383
Product ID
50383-824_a4f2a602-e08e-46ec-aaa0-6b18841079d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Akorn Operating Company LLC
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
Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-824-162024-01-30C16284748780-11030e365-1e68-111a-e063-dadaa90a10e2SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP
50383-824-212024-01-30C16284748780-11030e365-1e68-111a-e063-dadaa90a10e2SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-824-16Sulfamethoxazole and Trimethoprim473 mL in 1 BOTTLESUSPENSION47314
50383-824-20Sulfamethoxazole and Trimethoprim20 mL in 1 CUP, UNIT-DOSESUSPENSION2014
50383-824-21Sulfamethoxazole and Trimethoprim4 in 1 CASESUSPENSION414
50383-824-21Sulfamethoxazole and Trimethoprim10 in 1 TRAYSUSPENSION1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-824-16ML - Milliliter50383-8241ef73882-9901-4f29-a943-9fa0fc6de51112012-07-24
50383-824-20ML - Milliliter50383-824723efc5a-c3d0-4ccd-8bde-1ea07372c97e12013-10-17
50383-824-21ML - Milliliter50383-8246c4e34b7-a223-4ae5-a74d-34fc8a9eca4012013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
ALCOHOLINACTIVE INGREDIENT3K9958V90MSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
SORBITOLINACTIVE INGREDIENT506T60A25RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [HI-TECH PHARMACAL CO., INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-824SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AKORN OPERATING COMPANY LLC]14Legacy NDC, 4 package rows20221018_06e3d76b-8f16-4d53-bb9f-201cb6a72fb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN06e3d76b-8f16-4d53-bb9f-201cb6a72fb814
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD06e3d76b-8f16-4d53-bb9f-201cb6a72fb814
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY06e3d76b-8f16-4d53-bb9f-201cb6a72fb814
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY06e3d76b-8f16-4d53-bb9f-201cb6a72fb814
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY06e3d76b-8f16-4d53-bb9f-201cb6a72fb814
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY06e3d76b-8f16-4d53-bb9f-201cb6a72fb814
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNf4241086-b03c-765f-e053-2a95a90aa3f52
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDf4241086-b03c-765f-e053-2a95a90aa3f52
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYf4241086-b03c-765f-e053-2a95a90aa3f52
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYf4241086-b03c-765f-e053-2a95a90aa3f52
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYf4241086-b03c-765f-e053-2a95a90aa3f52
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYf4241086-b03c-765f-e053-2a95a90aa3f52
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN2e44d04e-e75c-4f4f-9d25-2d2fbfe8521c1
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD2e44d04e-e75c-4f4f-9d25-2d2fbfe8521c1
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY2e44d04e-e75c-4f4f-9d25-2d2fbfe8521c1
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY2e44d04e-e75c-4f4f-9d25-2d2fbfe8521c1
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY2e44d04e-e75c-4f4f-9d25-2d2fbfe8521c1
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY2e44d04e-e75c-4f4f-9d25-2d2fbfe8521c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-824-1650383082416473 mL in 1 BOTTLE (50383-824-16) 473 ml1997-12-290000-00-00NoNoCurrent
50383-824-205038308242020 mL in 1 CUP, UNIT-DOSE20 mlHistorical
50383-824-21503830824214 TRAY in 1 CASE (50383-824-21) > 10 CUP, UNIT-DOSE in 1 TRAY > 20 mL in 1 CUP, UNIT-DOSE (50383-824-20) 4 tray2014-12-240000-00-00NoNoCurrent