FDA.reportPublic FDA data

NDC 80425-0486-01 - 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
80425-0486
Requested NDC
80425-0486-01
Package NDCs from labels
80425-0486-1, 80425-0486-2, 80425-0486-3, 80425-0486-4, 80425-0486-5, 80425-0486-01
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
80425-0486-1Prednisone21 in 1 BOTTLETABLET212
80425-0486-2Prednisone14 in 1 BOTTLETABLET142
80425-0486-3Prednisone10 in 1 BOTTLETABLET102
80425-0486-4Prednisone15 in 1 BOTTLETABLET152
80425-0486-5Prednisone20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0486PREDNISONE TABLET [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 5 package rows20250410_30956dd5-fe19-d5a9-e063-6394a90a2549.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0486-1EA - Each80425-048614b47980-5e35-4c21-81e3-9783b105b21412025-05-14
80425-0486-2EA - Each80425-0486ec265645-937d-4699-9c0a-e0f5196c43c812025-05-14
80425-0486-3EA - Each80425-048656012a15-551c-4149-896d-54de13c6022712025-05-14
80425-0486-4EA - Each80425-0486c41b5398-3087-42d4-bbc9-1eb784ab9acc12025-05-14
80425-0486-5EA - Each80425-048652b341a3-b8aa-4964-bd16-6b9c29c8b88812025-05-14

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 11 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONEBryant Ranch Prepacka2ba1a31-9e2d-4c1e-9bbd-b813831ce08f2024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.62ff1da3-79aa-676a-e053-2991aa0a4a9f2024-07-19Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.1c59f8a1-e287-865f-e063-6394a90aa3302024-07-03Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.1c33879e-8b2b-5843-e063-6294a90adea42024-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA211575
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions751b7f62-f92b-4b7c-a588-2c882d5d1ce32024-06-25Warnings, Adverse reactionsExact identifier
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEActavis Pharma, Inc.aa0b1582-6ef3-4697-9ea6-5391e6e578532024-06-18Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 763183
rxcui: 763179
rxcui: 763181
rxcui: 763185
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.7e541478-4a33-189f-e053-2a91aa0a69622024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions8f7a38c7-7bf9-4951-b529-947cc9a57d6a2024-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA211575
rxcui: 198148
unii: VB0R961HZT
prednisonePREDNISONEA-S Medication Solutionsc7c3bb80-73b6-4128-aa5f-0d465a1d84e82024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutionscb1b0dc0-6916-4e6f-9775-26ea0f593f832024-06-03Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PREDNISONEPREDNISONEBryant Ranch Prepack72367ecf-579e-4ef9-8119-54fd46a079b62024-05-30Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PREDNISONEPREDNISONEBryant Ranch Prepack7601e38d-b7d2-4292-b16e-abff32bb46b32024-05-29Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT
PREDNISONEPREDNISONEBryant Ranch Prepack29c96865-48be-4898-81b7-a6fc9623d3b92024-05-28Warnings, Adverse reactionsExact identifier
rxcui: 198146
unii: VB0R961HZT
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
PrednisonePREDNISONEProficient Rx LP94f8ec56-667e-4eda-832d-f2936f12dc362024-05-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63106192-35d5-6989-e053-2991aa0aa7142024-04-25Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.db4a13ff-546d-15b7-e053-2a95a90a6adf2024-04-23Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d22024-04-02Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 368GB5141J
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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