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 4 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and Trimethoprim DSSULFAMETHOXAZOLE AND TRIMETHOPRIMAdvanced Rx Pharmacy of Tennessee, LLCb000150f-3be6-2e6c-e053-2995a90a67d52024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA090624
ndc (package): 80425-0002-1
ndc (product): 80425-0002
ndc11 (package): 80425000201
rxcui: 198335
spl id: 2a9804bb-d5c4-5a9a-e063-6294a90a973d
spl set id: b000150f-3be6-2e6c-e053-2995a90a67d5
unii: AN164J8Y0X
unii: JE42381TNV
BactrimSULFAMETHOXAZOLE AND TRIMETHOPRIMSun Pharmaceutical Industries, Incf59d0c04-9c66-4d53-a0e1-cb55570deb622024-12-30Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMQuality Care Products LLC079c828c-148f-45b9-966e-d8906043b2a22024-12-17Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAurobindo Pharma Limiteda6182855-6287-45e9-b6b4-7b57efc9c76e2024-12-02Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPrasco Laboratories6111a3c9-1406-4337-8b55-0f33120af8192024-11-18Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions7d7ca48b-8655-4cfb-8db0-28eddf1feb9b2024-10-25Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMBryant Ranch Prepacka174991a-53e7-c791-3cee-b706a48e0ec52024-10-09Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMBryant Ranch Prepack27bebe39-c069-4a9d-99d1-c7cf44ac2f412024-10-07Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals, Inc.3ed6bf70-2841-04f8-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals, Inc.46dc8f62-e700-50e3-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
polymyxin b sulfate and trimethoprim sulfatePOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATESomerset Therapeutics, LLC93d52a75-9a96-4f96-be41-9ccdcabc09332024-08-06Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPAI Holdings, LLC dba PAI Pharma777da85a-a776-4681-976d-326ec421cfc92024-08-01Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
TrimethoprimTRIMETHOPRIMLupin Pharmaceuticals,Inc.249e938d-f181-47c4-a082-372d65462f332024-06-04Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPharmasource Meds, LLCf564a029-4b20-301a-e053-2995a90adcc02024-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNCS HealthCare of KY, LLC dba Vangard Labsc2307cc2-43ee-4319-ad58-d1d28a95e5aa2024-02-05Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMChartwell RX, LLCe4a7572f-b372-40eb-963f-919ac100b7a82024-01-31Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
TrimethoprimTRIMETHOPRIMDr. Reddy's Labratories Inc.73ccebc1-7412-2424-d62c-a5180ec52d812024-01-26Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsf39a4c93-0a0e-4801-aecc-c55a2fa5e68b2024-01-08Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsffc5d594-429c-4303-b3b6-f5a83e915b552024-01-08Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions07a49665-fe2a-4a92-a57e-49db224b012e2024-01-08Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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