FDA.reportPublic FDA data

NDC 80425-0484-01 - 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
80425-0484
Requested NDC
80425-0484-01
Package NDCs from labels
80425-0484-1, 80425-0484-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-04-04
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, LLC2025-04-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0484-1prednisone21 in 1 BOTTLE, PLASTICTABLET213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0484PREDNISONE TABLET [ADVANCED RX OF TENNESSEE, LLC]3Current NDC, 1 package rows20250410_2d0562ad-6175-833c-e063-6394a90ad029.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0484-1EA - Each80425-048445631ccf-0e70-47eb-ac42-a4023e1fc60f12025-03-04

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 4 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONESportpharm LLC5dde7256-d3b8-400d-a0eb-c60078bfc5d92026-04-24Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198148
unii: VB0R961HZT
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
prednisonePREDNISONEAmneal Pharmaceuticals NY LLC0740ef68-7641-432e-bd46-4710687fc9d72026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEREMEDYREPACK INC.4bd86b2f-75cb-4711-85e2-b81ed947cb132026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.e9a74862-6a3b-4247-837a-389761b5c3522026-04-13Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.b540f4af-8f07-4c56-b151-d759440c514a2026-04-13Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198148
unii: VB0R961HZT
Prednisone D/PPREDNISONE D/PDirect_Rx4f0a3946-025c-798a-e063-6294a90a831b2026-04-09Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEBryant Ranch Prepack70d05ed7-5c4e-4cd1-84cd-0dbe90692c542026-04-09Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198148
unii: VB0R961HZT
PrednisonePREDNISONENorthwind Health Company, LLCfbd3f0c3-06b3-c9b4-e053-6294a90a6fdd2026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT
PredniSONE Tablets, USP, 5 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e2026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.3befbdc5-7d20-41b6-ad80-98e1c6b8caf52026-03-27Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONEA-S Medication Solutions53c66f70-58fd-4d4c-b054-e5cefdc0c6372026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONE Tablets, USP, 5 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.d6df3295-3118-49af-be05-b1fab0d4adaa2026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONE Tablets, USP, 10 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.14d50f54-410b-45b2-a639-31498ceaf8542026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutionsb5b088b9-8f90-468f-b7a4-a5274aa0aec92026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
Prednisone D/PPREDNISONE D/PDirect_Rx41ade439-59f2-dfd1-e063-6294a90aca0f2026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PREDNISONEPREDNISONEDIRECT RX2a053775-6f6a-455e-b9a8-8b60e6062db32026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PREDNISONEPREDNISONEA-S Medication Solutionse753e2bc-acca-46eb-888c-ae72fcac6ca42026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PREDNISONEPREDNISONEA-S Medication Solutionsa8f6298a-1084-4226-bfd9-a543a26ad2e72026-03-13Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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