FDA.reportPublic FDA data

NDC 80425-0482-01 - 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
80425-0482
Requested NDC
80425-0482-01
Package NDCs from labels
80425-0482-1, 80425-0482-01
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
80425-0482-1prednisone21 in 1 BOTTLE, PLASTICTABLET213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0482PREDNISONE 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
80425-0482-1EA - Each80425-0482a9d21b65-5a21-49d5-9e1d-d62308b17e5712025-03-04

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 6 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PredniSONEPREDNISONENorthwind Health Company, LLCca39fdfb-d110-6535-e053-2995a90a550a2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PredniSONEPREDNISONENorthwind Health Company, LLCda6fce58-0ef9-f3b1-e053-2995a90a1bec2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198146
unii: VB0R961HZT
PrednisonePREDNISONENorthwind Health Company, LLCda7f948f-8039-5f0d-e053-2a95a90ad0f02026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONENorthwind Health Company, LLCf7e523ab-d831-6acf-e053-6294a90a79a32026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA208412
unii: VB0R961HZT
PrednisonePREDNISONENorthwind Health Company, LLCf76db82a-826e-92b0-e053-6294a90a8ec62026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PredniSONEPREDNISONENorthwind Health Company, LLCf77f4a5a-b307-84ff-e053-6294a90aba5b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT
prednisonePREDNISONENorthwind Health Company, LLCe08ba8c5-5e26-6120-e053-2995a90a13642026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONEPREDNISONENorthwind Health Company, LLCc9f4711d-319c-d952-e053-2a95a90a36972026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONENorthwind Health Company, LLCfc4cd6f4-e01f-ad2d-e053-6294a90aebd62026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 312615
unii: VB0R961HZT
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
prednisonePREDNISONERedpharm Drug0ab0e81c-8170-6805-e063-6294a90adfc02025-12-25Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEAmerican Health Packaginga0e8d1a2-8c82-4dc0-8c2f-9da84382f34e2025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEA-S Medication Solutionse28359cf-0c21-487a-a1a3-d1c62cef88f92025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONEA-S Medication Solutions35de14e3-d748-46bd-a307-6a1a27c626a22025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 198146
unii: VB0R961HZT
Prednisone delayed releasePREDNISONEINA Pharmaceutics Inc463c7cd2-c973-5c6c-e063-6394a90a09a02025-12-17Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
prednisonePREDNISONEStrides Pharma Science Limited2ef05381-faad-4e0f-b58d-9f2236a04a2c2025-12-15Warnings, Adverse reactionsExact identifier
application number: ANDA208412
ndc (product): 64380-784
ndc (product): 64380-785
rxcui: 198145
rxcui: 312615
rxcui: 198148
spl id: bdf0b63b-7d6e-4799-be31-cdbf94e02145
spl set id: 2ef05381-faad-4e0f-b58d-9f2236a04a2c
unii: VB0R961HZT
PREDNISONEPREDNISONERedpharm Drug44f5e966-5a12-e2ff-e063-6294a90a919e2025-12-13Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEChartwell RX, LLC36631112-3abb-4003-886b-9fe6d9cbe2cc2025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEChartwell RX, LLCf532c919-765d-407a-9e01-db2dc0c006f52025-12-11Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
prednisonePREDNISONEStrides Pharma Science Limited52010a34-aadb-4561-ac4a-3ee53f5e35662025-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA208412
ndc (product): 64380-783
rxcui: 198146
rxcui: 312617
spl id: c389b525-c68a-43dc-bacc-c75707b391b5
spl set id: 52010a34-aadb-4561-ac4a-3ee53f5e3566
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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