FDA.reportPublic FDA data

NDC 50383-824-20 - Sulfamethoxazole and Trimethoprim

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50383-824
Requested NDC
50383-824-20
Package NDCs from labels
50383-824-16, 50383-824-20, 50383-824-21
Manufacturer
Redpharm Drug, Inc. | Akorn Operating Company LLC
Effective date
2024-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALCOHOL - Redpharm Drug, Inc. | Akorn Operating Company LLCRedpharm Drug, Inc. | Akorn Operating Company LLC2024-08-01HUMAN PRESCRIPTION DRUG LABEL
Sulfamethoxazole and Trimethoprim - Akorn Operating Company LLCAkorn Operating Company LLC2022-10-14HUMAN PRESCRIPTION DRUG LABEL
Sulfamethoxazole and Trimethoprim - A-S Medication SolutionsA-S Medication Solutions2021-01-14HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 179 · 3,562 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
polymyxin b sulfate and trimethoprim sulfatePOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEREMEDYREPACK INC.c68818b2-d849-41d2-be07-731244afbbac2026-09-09Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.