FDA.reportPublic FDA data

NDC 68084-747-95 - 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
68084-747
Requested NDC
68084-747-95
Package NDCs from labels
68084-747-95, 68084-747-25
Manufacturer
American Health Packaging
Effective date
2020-04-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfamethoxazole and Trimethoprim - American Health PackagingAmerican Health Packaging2020-04-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-747-25EA - Each68084-747555a5d73-e63f-4e7a-b432-5d7f310e893e12014-07-02
68084-747-95EA - Each68084-7472cc2e389-a9ec-415d-86dd-a99686859d2912014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
POVIDONESINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]4

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 8 of 9 · 161 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsb85a58a7-74d6-4629-8027-0cdcbb5c815a2023-12-17Warnings, Adverse reactionsExact identifier
application number: ANDA076899
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions07da67b1-b50c-4471-8cde-8a119eb8c9352023-12-15Warnings, Adverse reactionsExact identifier
application number: ANDA076899
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LPbefcc5b0-04bb-4211-b3dd-88f400c7fa782023-08-01Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
TrimethoprimTRIMETHOPRIMGolden State Medical Supply, Inc.f756f4be-3cda-ab98-e053-6294a90a14242023-03-20Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsd8239804-d234-491b-965d-89a7796a5e4d2023-02-04Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMDenton Pharma, Inc. DBA Northwind Pharmaceuticalsa12bf393-d8ef-48df-e053-2a95a90a1af12023-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethox-TMP DSSULFAMETHOXAZOLE, TRIMETHOPRIMPharmPak, Inc.ede74118-32c5-4f52-9823-509538e674c82022-10-09Warnings, Adverse reactionsExact identifier
application number: ANDA076899
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LPc407381f-3d8e-4fdf-9132-cd39680992962022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
TrimethoprimTRIMETHOPRIMNovitium Pharma LLC95a1572c-6109-4d1f-bf92-262015a7654e2022-08-02Warnings, Adverse reactionsExact identifier
unii: AN164J8Y0X
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP29e83667-8d4a-49b7-9182-653cbfb2dee72022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAsclemed USA, Inc.e6c0f80a-ba22-4690-aaf8-48a4602b68312020-09-04Warnings, Adverse reactionsExact identifier
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
a2dbdcac-27e3-3b8f-e053-2995a90af1530c3ab79b-cdf4-4a67-b6d9-6c89d7cd4fc12020-04-09Warnings, Adverse reactionsExact identifier
spl id: a2dbdcac-27e3-3b8f-e053-2995a90af153
spl set id: 0c3ab79b-cdf4-4a67-b6d9-6c89d7cd4fc1
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMVista Pharmaceuticals, Inc.3edca473-8fdc-462a-b378-6c3279503a702020-01-22Warnings, Adverse reactionsExact identifier
rxcui: 198334
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP0df74ba1-1aa6-467c-92e7-6b017c7c6bce2019-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA076899
rxcui: 198335
unii: AN164J8Y0X
unii: JE42381TNV

Reported adverse events (FAERS/openFDA)#

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