FDA.reportPublic FDA data

NDC 63629-9715-01 - 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
63629-9715
Requested NDC
63629-9715-01
Package NDCs from labels
63629-9715-1, 63629-9715-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-04-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sulfasalazine - Bryant Ranch PrepackBryant Ranch Prepack2024-04-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9715-1Sulfasalazine90 in 1 BOTTLE, PLASTICTABLET90101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9715SULFASALAZINE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240509_618c5324-d0a6-4d00-9b12-0de88a71c180.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 1 of 1 ยท 19 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
rxcui: 198232
unii: 3XC8GUZ6CB
AzulfidineSULFASALAZINEPfizer Laboratories Div Pfizer Incddbe69f3-bd55-45f3-a64f-f60226c744c42026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 198232
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
rxcui: 198232
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINESunrise Pharmaceutical, Inc.a54b31cc-205d-43d3-a850-acf4b41fbc372025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 198232
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEA-S Medication Solutions76b532a3-e7ca-4929-8c51-c0f66e0806a82025-04-08Warnings, Adverse reactionsExact identifier
rxcui: 198232
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEA-S Medication Solutions32fd1726-ed81-4441-9594-3aecf2db1dbf2025-04-08Warnings, Adverse reactionsExact identifier
rxcui: 198232
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEBryant Ranch Prepack618c5324-d0a6-4d00-9b12-0de88a71c1802024-04-04Warnings, Adverse reactionsExact identifier
application number: ANDA085828
ndc (package): 63629-9715-1
ndc (product): 63629-9715
ndc11 (package): 63629971501
rxcui: 198232
spl id: 00104d3b-3b62-49fb-8a04-26ec7c24efcc
spl set id: 618c5324-d0a6-4d00-9b12-0de88a71c180
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
ndc (product): 0093-3234
rxcui: 198232
spl id: 6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471
spl set id: 3c59593b-e1a5-47cb-a82b-3e5e49205344
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEAphena Pharma Solutions - Tennessee, LLCbf5137fe-60ed-4497-8521-eeb0a684fabf2023-05-16Warnings, Adverse reactionsExact identifier
rxcui: 198232
unii: 3XC8GUZ6CB
SulfasalazineSULFASALAZINEChartwell RX, LLC.029716bd-ee1a-484c-bf1f-ec8d02d5281b2022-12-12Warnings, Adverse reactionsExact identifier
rxcui: 198232
unii: 3XC8GUZ6CB

Reported adverse events (FAERS/openFDA)#

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