FDA.reportPublic FDA data

NDC 68071-4948-06 - 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
68071-4948
Requested NDC
68071-4948-06
Package NDCs from labels
68071-4948-2, 68071-4948-4, 68071-4948-6, 68071-4948-06
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-01-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim Tablets, USPNuCare Pharmaceuticals,Inc.2026-01-05HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4948-22024-06-18Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4948-42024-06-18Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4948-22023-01-30Sulfamethoxazole and Trimethoprim Tablets, USP
68071-4948-42023-01-30Sulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4948-2Sulfamethoxazole and Trimethoprim2 in 1 BOTTLETABLET25
68071-4948-4Sulfamethoxazole and Trimethoprim4 in 1 BOTTLETABLET45
68071-4948-6Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4948SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 3 package rows20240619_8c3e4738-0e0a-a854-e053-2995a90a7d71.zip

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 7 of 22 · 437 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMStrategic Sourcing Services LLC24e29f00-f1cf-4e92-bd67-3f6f820af7832026-01-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLC33000a06-e030-433a-8f9c-7ae5c08037fa2026-01-06WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Regular StrengthDOCUSATE SODIUMSam's West, Inc1eca5910-b0bf-4e07-8211-36dba52b3de72026-01-06WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNuCare Pharmaceuticals,Inc.8c3e4738-0e0a-a854-e053-2995a90a7d712026-01-05Warnings, Adverse reactionsExact identifier
application number: ANDA090624
ndc (package): 68071-4948-6
ndc (package): 68071-4948-2
ndc (package): 68071-4948-4
ndc (product): 68071-4948
ndc11 (package): 68071494806
rxcui: 198335
spl id: 47acdd43-4e46-66bc-e063-6394a90a9c04
spl set id: 8c3e4738-0e0a-a854-e053-2995a90a7d71
unii: AN164J8Y0X
unii: JE42381TNV
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions80f7f00b-add4-4d6b-9e9c-bea29768c2392026-01-05Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
unii: JE42381TNV
Senna SDOCUSATE SODIUM, SENNOSIDESSafeway, Inc.acb40b29-5fd5-4864-b6bf-4102e47a16832026-01-05WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLCf2b8e9d9-1274-22ca-e053-2a95a90a6f1a2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLCf7f97520-d063-ec87-e053-6294a90aae0c2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Senna-SSENNOSIDES AND DOCUSATE SODIUMRMT HEALTH LLC4742182e-fdf9-44fe-e063-6394a90adfcc2025-12-31WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact identifier
unii: F05Q2T2JA0
Senna-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGWalgreens36cc3a5b-1891-d39e-e063-6294a90a93b42025-12-31WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium LiquidDOCUSATE SODIUMRUGBY LABORATORIESe21d19d8-6c2d-4474-a663-dfe7e91ac3202025-12-30WarningsExact identifier
unii: F05Q2T2JA0
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLC471c5995-a4df-fbe3-e063-6394a90aa50e2025-12-29Warnings, Adverse reactionsExact identifier
application number: ANDA090624
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Senna-SSENNA-SPioneer Life Sciences, LLCab46a3ca-6c7a-a81e-e053-2995a90a199f2025-12-29WarningsExact identifier
unii: F05Q2T2JA0
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGPharbest Pharmaceuticals, Inc.2b5152b2-d354-409f-a19f-b470f4181b3f2025-12-24WarningsExact identifier
unii: F05Q2T2JA0
Senna PlusDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER4d4101ca-7d78-4712-9b3d-f395f2646c6b2025-12-23WarningsExact identifier
unii: F05Q2T2JA0
Senna-SSENNOSIDES 8.6 MG AND DOCUSATE SODIUM 50 MGNUVICARE LLC9e999e4a-2f72-4a2b-a41b-bdd68bf5a3502025-12-19WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcb0765cb-f48e-4daa-97b8-2897a2d955872025-12-19WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMStrategic Sourcing Services LLCba51cca1-b70b-476e-80e6-20cd52292e652025-12-17WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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