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 2 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.7f82e5e0-b627-a3f3-e053-2991aa0abaa52026-02-09Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMSportpharm LLC52304e5e-d097-48f2-8b64-210908e4eb542026-02-03Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMREMEDYREPACK INC.99e1ace6-7665-4f87-82fd-5e7c4989e0982026-01-13Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfameth/Trimeth-DSSULFAMETH/TRIMETH-DSDirect_Rx90026ce8-3305-6272-e053-2995a90a57e02026-01-08Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.8c3e4738-0e0a-a854-e053-2995a90a7d712026-01-05Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions80f7f00b-add4-4d6b-9e9c-bea29768c2392026-01-05Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLCf2b8e9d9-1274-22ca-e053-2a95a90a6f1a2026-01-01Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLCf7f97520-d063-ec87-e053-6294a90aae0c2026-01-01Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLC471c5995-a4df-fbe3-e063-6394a90aa50e2025-12-29Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMQPharma, Inc.41529314-b203-47f4-88dd-5aa57c74985f2025-12-02Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMMajor Pharmaceuticalsabe0d2d5-4879-4b4e-9b57-47ea83a17ba02025-11-18Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMVERITYRX, LLC427b8040-99a4-8e81-e063-6394a90a76c52025-10-31Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.1274cefb-0799-e2e4-e063-6394a90aad022025-10-07Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmerican Health Packaging7f25bff3-0e86-4bec-b293-54b68347867f2025-07-23Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
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
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
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMKesin Pharma31f9e720-3869-061f-e063-6294a90a43b42025-05-13Warnings, Adverse reactionsExact identifier
application number: ANDA077612
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

Reported adverse events (FAERS/openFDA)#

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