FDA.reportPublic FDA data

NDC 68084-747-95 - 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
68084-747
Requested NDC
68084-747-95
Package NDCs from labels
68084-747-95, 68084-747-25
Manufacturer
American Health Packaging
Effective date
2020-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim - American Health PackagingAmerican Health Packaging2020-04-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-747-25EA - Each68084-747555a5d73-e63f-4e7a-b432-5d7f310e893e12014-07-02
68084-747-95EA - Each68084-7472cc2e389-a9ec-415d-86dd-a99686859d2912014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4

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 5 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSomerset Therapeutics, LLCebb570bb-6e5e-489e-875c-9e7b3a6d716a2025-07-16Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMGolden State Medical Supply, Inc.bd3161fe-23d7-458a-86a4-fb958d9c94d32025-06-06Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmerican Health Packagingf14b8d07-e73b-4ceb-bd6a-578c961b7c092025-05-16Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d2025-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA076899
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMKesin Pharma31f9e720-3869-061f-e063-6294a90a43b42025-05-13Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.bf7a0845-de4f-46be-841a-0faf47f8b5302025-04-30Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPD-Rx Pharmaceuticals, Inc.c4da9c4f-0704-4ed5-9d19-5c949f37f7262025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.b89b5502-ce87-45a6-a43c-9891da3cfca42025-04-30Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.640f5b0c-748d-4a68-a1de-59cc3e00ed492025-04-30Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSun Pharmaceutical Industries, Inc.4833319a-a7b3-4bf4-bec4-6531b43182d42025-04-03Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCronus Pharma LLC1b5de94f-973a-4b5a-91d7-45e05be786502025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMRising Pharma Holdings, Inc.e1a3748d-ca73-4e56-95ad-d25189cc346e2025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions62616708-a538-459f-9b7f-ed90c6aa5fc62025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions14767ff8-7803-4922-ac03-ff80c061e5ba2025-03-31Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsfd90d8bd-1b84-4347-a98a-f8f94746f3e42025-03-31Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions4e12b7e1-fa2f-4cd1-ada6-19a7d56523482025-03-31Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMChartwell RX, LLCb5b7aba5-f93d-46bc-a3c2-712de1c5cff32025-03-28Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPD-Rx Pharmaceuticals, Inc.3ef62512-0dc3-4821-9b60-6b375841c4c02025-03-26Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAurobindo Pharma Limited284b5dac-2b8d-46bf-95fe-80ce03fa178a2025-03-12Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMPAI Holdings, LLC dba PAI Pharmac62086ea-ba15-40f5-8431-4639c60c98252025-03-06Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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