FDA.reportPublic FDA data

NDC 00093-5476 - 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
00093-5476
Manufacturer
Pharmaceutical Associates, Inc. | Teva Pharmaceuticals, USA
Effective date
2009-12-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole - Pharmaceutical Associates, Inc. | Teva Pharmaceuticals, USAPharmaceutical Associates, Inc. | Teva Pharmaceuticals, USA2009-12-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SulfamethoxazoleACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
TrimethoprimACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
SulfamethoxazoleACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1
TrimethoprimACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]1

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 · 96 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
unii: AN164J8Y0X
unii: JE42381TNV
BactrimSULFAMETHOXAZOLE AND TRIMETHOPRIMSun Pharmaceutical Industries, Incf59d0c04-9c66-4d53-a0e1-cb55570deb622024-12-30Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMQuality Care Products LLC079c828c-148f-45b9-966e-d8906043b2a22024-12-17Warnings, Adverse reactionsExact identifier
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
application number: ANDA077612
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions7d7ca48b-8655-4cfb-8db0-28eddf1feb9b2024-10-25Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMBryant Ranch Prepacka174991a-53e7-c791-3cee-b706a48e0ec52024-10-09Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMBryant Ranch Prepack27bebe39-c069-4a9d-99d1-c7cf44ac2f412024-10-07Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals, Inc.3ed6bf70-2841-04f8-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals, Inc.46dc8f62-e700-50e3-e054-00144ff8d46c2024-08-14Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
1f92faea-6f83-4fbe-e063-6394a90a7a0eafb1693a-63d4-4356-976a-51a2d8dcde682024-08-13Warnings, Adverse reactionsExact identifier
spl set id: afb1693a-63d4-4356-976a-51a2d8dcde68
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
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
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMChartwell RX, LLCe4a7572f-b372-40eb-963f-919ac100b7a82024-01-31Warnings, Adverse reactionsExact identifier
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
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsffc5d594-429c-4303-b3b6-f5a83e915b552024-01-08Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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