FDA.reportPublic FDA data

NDC 0591-5059-01 - Prednisolone

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
0591-5059
Requested NDC
0591-5059-01
Package NDCs from labels
0591-5059-01, 0591-5059-10
Manufacturer
Watson Laboratories, Inc.
Effective date
2007-03-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FPO Prednisolone Tablets USP Revised: June 2006 Rx onlyWatson Laboratories, Inc.2007-03-31HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5059-01Prednisolone100 in 1 BOTTLETABLET1001
0591-5059-10Prednisolone1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5059PREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]12 package rows20070420_A0EEEC15-C76D-41DF-80F3-5572C9857DA6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PrednisoloneACTIVE INGREDIENT9PHQ9Y1OLMPREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
PrednisoloneACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
anhydrous lactoseINACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
collodial silicon dioxideINACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
crospovidoneINACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
D & C Yellow # 10INACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0PREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
FD & C Yellow #6INACTIVE INGREDIENTPREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPREDNISOLONE (PREDNISOLONE) TABLET [WATSON LABORATORIES, INC.]1

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 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISOLONEPREDNISOLONEZhejiang Xianju Pharmaceutical Co., Ltd.52e6e21d-94b8-41a0-8d13-371c0e66bcee2026-01-05Warnings, Adverse reactionsExact identifier
rxcui: 198142
PREDNISOLONEPREDNISOLONEHisun Pharmaceuticals USA, Inc.16d4e064-66d3-4497-8c7d-3aa355f91e1d2024-08-15Warnings, Adverse reactionsExact identifier
rxcui: 198142
PrednisolonePREDNISOLONEChartwell RX, LLC2e965355-f7f2-4dd3-9c5c-1524c6f39c912024-06-17Warnings, Adverse reactionsExact identifier
rxcui: 198142
PREDNISOLONEPREDNISOLONEAurobindo Pharma Limited070f1937-50a5-457f-bef5-4e597014e26d2024-02-16Warnings, Adverse reactionsExact identifier
rxcui: 198142
5252C72B-2E45-4913-3FC8-A8942C1A8424A0EEEC15-C76D-41DF-80F3-5572C9857DA62007-03-31Warnings, Adverse reactionsExact identifier
spl id: 5252C72B-2E45-4913-3FC8-A8942C1A8424
spl set id: A0EEEC15-C76D-41DF-80F3-5572C9857DA6

Reported adverse events (FAERS/openFDA)#

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