FDA.reportPublic FDA data

NDC 0703-9503-01 - 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
0703-9503
Requested NDC
0703-9503-01
Package NDCs from labels
0703-9503-01, 0703-9503-03
Manufacturer
Teva Parenteral Medicines, Inc.
Effective date
2025-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim - Teva Parenteral Medicines, Inc.Teva Parenteral Medicines, Inc.2025-04-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0703-9503-01Sulfamethoxazole and Trimethoprim5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE518
0703-9503-03Sulfamethoxazole and Trimethoprim10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE1018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0703-9503SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]17Current NDC, Legacy NDC, 2 package rows20250510_b89b5502-ce87-45a6-a43c-9891da3cfca4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-9503-01ML - Milliliter0703-9503f616736c-aa21-4814-97ce-34c43124b90612021-05-05
0703-9503-03ML - Milliliter0703-9503afbb5a59-dbfa-4b31-a67e-2eb5606f3d1812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
ALCOHOLINACTIVE INGREDIENT3K9958V90MSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
DIETHANOLAMINEINACTIVE INGREDIENTAZE05TDV2VSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RSULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.]9

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 97 of 158 · 3,158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Holiday Hand Sanitizer - CaramelALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ec6817-98e4-2d8c-e063-6394a90ad5df2025-05-12WarningsExact identifier
unii: 3K9958V90M
Meijer Hydrating Power Mist Hand Sanitizer - GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.34ecbd68-ddab-3e47-e063-6294a90a2e502025-05-12WarningsExact identifier
unii: 3K9958V90M
Novo wipeALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.4ea50d30-b75b-44dc-bda1-d3ac97b34af72025-05-12WarningsExact identifier
unii: 3K9958V90M
meijer VANILLA SUGAR SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.41d754fb-1417-498e-b7a3-55ffb1a9fcb32025-05-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Pumpkin ScentedALCOHOLFOURSTAR GROUP USA, INC.7ea6ec9d-323d-4f81-bc86-94cd0e6cc0142025-05-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Sugar Cookie ScentedALCOHOLFOURSTAR GROUP USA, INC.29448472-af23-4ed2-93a9-9d57b7d8d0812025-05-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Ginger Citrus ScentedALCOHOLFOURSTAR GROUP USA, INC.100184a8-6298-4c57-a831-cd5fa55a66b02025-05-07WarningsExact identifier
unii: 3K9958V90M
meijer WATERMELON SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.9dc31149-9ba1-4014-9a51-21e558652ca52025-05-06WarningsExact identifier
unii: 3K9958V90M
meijer BERRY SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.7bbd6459-0cb6-4b48-b842-0d585295ed802025-05-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Mocha Coffee ScentedALCOHOLFOURSTAR GROUP USA, INC.8130954d-ba43-478d-b260-b74eaa2ab3752025-05-05WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Almond Vanilla ScentedALCOHOLFOURSTAR GROUP USA, INC.e9628d75-6271-47f7-8e96-cc06b2496b3b2025-05-05WarningsExact identifier
unii: 3K9958V90M
Nozin Nasal Sanitizer (Antiseptic)ALCOHOLGlobal Life Technologies Corp.c670ac11-0656-4d85-868e-3a407c9952a32025-05-05WarningsExact identifier
unii: 3K9958V90M
Mt Royal Hand Sanitizer70% ETHYL ALCOHOL GELMount Royal Soaps, LLCa25f5362-b868-5f47-e053-2995a90a05a72025-05-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a703b9-bcec-55ab-e063-6294a90af7822025-05-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a73f9f-faa2-89d5-e063-6294a90a4e0c2025-05-01WarningsExact identifier
unii: 3K9958V90M
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.bf7a0845-de4f-46be-841a-0faf47f8b5302025-04-30Warnings, Adverse reactionsExact identifier
application number: ANDA073303
ndc (product): 0703-9514
ndc (product): 0703-9526
rxcui: 313137
spl id: 03a1a8ab-99e0-4f3a-bcd8-79a902eaf27e
spl set id: bf7a0845-de4f-46be-841a-0faf47f8b530
unii: AN164J8Y0X
unii: JE42381TNV
Sterillium MedALCOHOLBODE Chemie GmbH8d80d5fd-7869-c551-e053-2995a90af2a92025-04-30WarningsExact identifier
unii: 3K9958V90M
Sterillium ComfortALCOHOLBODE Chemie GmbH8efc9f4e-3b20-60ba-e053-2995a90af8b12025-04-30WarningsExact identifier
unii: 3K9958V90M
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.b89b5502-ce87-45a6-a43c-9891da3cfca42025-04-30Warnings, Adverse reactionsExact identifier
application number: ANDA073303
ndc (package): 0703-9503-03
ndc (package): 0703-9514-01
ndc (package): 0703-9514-03
ndc (package): 0703-9503-01
ndc (package): 0703-9526-01
ndc (product): 0703-9514
ndc (product): 0703-9526
ndc (product): 0703-9503
ndc11 (package): 00703950301
rxcui: 313137
rxcui: 1809083
spl id: 75bddfb3-c199-47a4-b54a-a74cef7dec9a
spl set id: b89b5502-ce87-45a6-a43c-9891da3cfca4
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMTeva Parenteral Medicines, Inc.640f5b0c-748d-4a68-a1de-59cc3e00ed492025-04-30Warnings, Adverse reactionsExact identifier
application number: ANDA073303
ndc (product): 0703-9514
rxcui: 313137
spl id: bb9ad1b0-6df3-4878-9008-453c104c4f48
spl set id: 640f5b0c-748d-4a68-a1de-59cc3e00ed49
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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