FDA.reportPublic FDA data

NDC 80425-0002-01 - Sulfamethoxazole and Trimethoprim DS

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
80425-0002
Requested NDC
80425-0002-01
Package NDCs from labels
80425-0002-1, 80425-0002-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim DS - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0002-1Sulfamethoxazole and TrimethoprimDS14 in 1 BOTTLETABLET145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0002SULFAMETHOXAZOLE AND TRIMETHOPRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_b000150f-3be6-2e6c-e053-2995a90a67d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0002-1EA - Each80425-00027d6ab01e-65ee-4f48-b095-f02ac744499e12023-06-06

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 3 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPD-Rx Pharmaceuticals, Inc.c4da9c4f-0704-4ed5-9d19-5c949f37f7262025-04-30Warnings, Adverse reactionsExact identifier
application number: ANDA090624
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
application number: ANDA090624
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
application number: ANDA090624
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
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions14767ff8-7803-4922-ac03-ff80c061e5ba2025-03-31Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsfd90d8bd-1b84-4347-a98a-f8f94746f3e42025-03-31Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions4e12b7e1-fa2f-4cd1-ada6-19a7d56523482025-03-31Warnings, Adverse reactionsExact identifier
application number: ANDA090624
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
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAurobindo Pharma Limited284b5dac-2b8d-46bf-95fe-80ce03fa178a2025-03-12Warnings, Adverse reactionsExact identifier
application number: ANDA090624
ndc (product): 65862-420
rxcui: 198334
rxcui: 198335
spl id: e4ea8e99-58d4-4c1b-b84c-db0838610059
spl set id: 284b5dac-2b8d-46bf-95fe-80ce03fa178a
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
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions8c74ea5c-d05e-4fc1-b980-aacaab56d4722025-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions20054147-811c-471a-8ec4-1b2903fe906e2025-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsa12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc2025-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmneal Pharmaceuticals of New York LLC3233c54d-484d-4550-b172-db8af47d1b7f2025-02-26Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and Trimethoprim DSSULFAMETHOXAZOLE AND TRIMETHOPRIMAdvanced Rx Pharmacy of Tennessee, LLCb001e648-2710-3ada-e053-2995a90a52f12024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and Trimethoprim DSSULFAMETHOXAZOLE AND TRIMETHOPRIMAdvanced Rx Pharmacy of Tennessee, LLCafe8cb1c-7cfd-3378-e053-2a95a90a4db62024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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