FDA.reportPublic FDA data

NDC 80425-0481-01 - PredniSONE

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
80425-0481
Requested NDC
80425-0481-01
Package NDCs from labels
80425-0481-1, 80425-0481-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-02-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PredniSONE - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-02-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0481-1PredniSONE21 in 1 BOTTLETABLET211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0481PREDNISONE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 1 package rows20250221_2e630aa1-eccd-f5eb-e063-6294a90a4745.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0481-1EA - Each80425-048178a4c5d2-4582-4562-a2d7-71abb6d712ff12025-03-04

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 13 of 13 · 249 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEProficient Rx LPa1bff575-cd79-4596-99f1-30a5fe8a8b4c2022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP35f504c3-1cf5-455d-8226-9ffeea6066232022-05-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP016d65c3-fff2-4e0c-9025-e2083cfa6a1f2022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP7d52bf53-76e3-4826-a12b-b16a8560bafc2021-05-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEAsclemed USA, Inc.dc663fd3-b149-48ae-a3f3-6abaa4808cc62020-08-28Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LPe4555299-af68-416f-8999-9bb703a45e772019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP7c650dc8-43f6-4257-81ed-c93b00202d062019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP7a92b171-52ca-4948-81fc-e9a30597c5d82019-10-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEAphena Pharma Solutions - Tennessee, LLCb902ed21-c776-4046-8fbc-9ce95b16b1392017-12-21Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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