FDA.reportPublic FDA data

NDC 50268-730-11 - Sulfasalazine

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
50268-730
Requested NDC
50268-730-11
Package NDCs from labels
50268-730-11, 50268-730-15
Manufacturer
AvPAK
Effective date
2022-01-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfasalazine - AvPAKAvPAK2022-01-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-730-11EA - Each50268-7300b9d17c0-c4e1-45a6-9244-6d2dec87d24112015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFASALAZINEACTIVE INGREDIENT3XC8GUZ6CBSULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
SULFASALAZINEACTIVE MOIETY3XC8GUZ6CBSULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSULFASALAZINE (SULFASALAZINE) TABLET [AVPAK]2

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 1 of 1 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.257cee60-b68f-4c2b-b57d-8e4d73d17e092026-08-25Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEMylan Pharmaceuticals Inc.48fbc535-a33a-45ee-85ff-9d1ec9b31d9c2026-08-25Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
AzulfidineSULFASALAZINEPfizer Laboratories Div Pfizer Incddbe69f3-bd55-45f3-a64f-f60226c744c42026-05-29Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
Azulfidine EN-tabsSULFASALAZINEPfizer Laboratories Div Pfizer Incb9ef541a-93c8-4428-ba45-398aa0b327d12026-05-29Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
SulfasalazineSULFASALAZINESunrise Pharmaceutical, Inc.d596ac59-b643-4181-80ba-f2db1cc3459c2025-12-11Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINERising Pharma Holdings, Inc.3254432e-87a4-4af0-afd1-d9e6f1b0efd42025-11-06Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINESunrise Pharmaceutical, Inc.a54b31cc-205d-43d3-a850-acf4b41fbc372025-09-15Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEA-S Medication Solutions76b532a3-e7ca-4929-8c51-c0f66e0806a82025-04-08Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEA-S Medication Solutions32fd1726-ed81-4441-9594-3aecf2db1dbf2025-04-08Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEBryant Ranch Prepack618c5324-d0a6-4d00-9b12-0de88a71c1802024-04-04Warnings, Adverse reactionsExact identifier
application number: ANDA085828
unii: 3XC8GUZ6CB
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
SulfasalazineSULFASALAZINETeva Pharmaceuticals USA, Inc.3c59593b-e1a5-47cb-a82b-3e5e492053442023-08-22Warnings, Adverse reactionsExact identifier
application number: ANDA085828
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEAphena Pharma Solutions - Tennessee, LLCbf5137fe-60ed-4497-8521-eeb0a684fabf2023-05-16Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEChartwell RX, LLC.029716bd-ee1a-484c-bf1f-ec8d02d5281b2022-12-12Warnings, Adverse reactionsExact identifier
unii: 3XC8GUZ6CB
e87e4e87-b3b3-5745-e053-2995a90a653767dcfa7d-f656-6c92-60bb-4b40dcecf0802022-09-12Warnings, Adverse reactionsExact identifier
spl set id: 67dcfa7d-f656-6c92-60bb-4b40dcecf080

Reported adverse events (FAERS/openFDA)#

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