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 2 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISONEPREDNISONEProficient Rx LPeabbefb2-21a9-4745-8021-1aac1ece7f9d2026-08-01Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT
PrednisonePREDNISONEPar Health USA, LLC10fe5a3b-84dc-4600-87c2-b80c97ce18cf2026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 198146
rxcui: 312615
rxcui: 763183
rxcui: 763179
rxcui: 763181
rxcui: 763185
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.5218e88b-468b-4d60-ab7e-78cca632b23a2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.19fdbf9f-3a64-b9fa-e063-6394a90af0862026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA211575
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1a9f00ac-ec92-4d2c-e063-6394a90ac4f62026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA211575
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.25b5958b-c151-9200-e063-6394a90af52c2026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA211575
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1349a022-639b-4494-99a2-1594c7c0f0e92026-07-21Warnings, Adverse reactionsExact identifier
application number: ANDA211575
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.288ecb6d-3b0b-db95-e063-6394a90a78ff2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONECardinal Health 107, LLCcdc2b903-5d86-45c1-b97c-2da48445dbdd2026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack6c0376c4-87cf-40dc-b140-a6aac75b64f72026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 198146
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack931171e2-0bdb-451e-b737-72ce3ffbed532026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack55aedced-d945-4bd2-9aa8-0f18b89a0e7f2026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEANI Pharmaceuticals, Inc.f05eb734-07e7-491c-b2e9-aae340e037502026-07-10Warnings, Adverse reactionsExact identifier
application number: ANDA211575
ndc (product): 70954-060
rxcui: 198145
rxcui: 198146
rxcui: 312615
rxcui: 763183
rxcui: 763179
rxcui: 763181
rxcui: 198148
rxcui: 763185
rxcui: 312617
spl id: f662b658-7133-468c-b35a-ed6083cbff91
spl set id: f05eb734-07e7-491c-b2e9-aae340e03750
unii: VB0R961HZT
prednisonePREDNISONEUnit Dose Solutions, Inc.5590d36d-dbe7-1c78-e063-6294a90ad2d42026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEAmneal Pharmaceuticals NY LLC03228706-92b9-43c9-8d73-c73aa124c58d2026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
PredniSONEPREDNISONESt. Mary's Medical Park Pharmacy16ee689e-c7a9-3a5a-e063-6394a90a6ea22026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONESt. Mary's Medical Park Pharmacy1b3ea4cc-5bc6-ae47-e063-6294a90af13d2026-06-15Warnings, Adverse reactionsExact identifier
application number: ANDA211575
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONERedpharm Drug5407a00b-1bfb-e37d-e063-6294a90a6c412026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONECoupler LLC53864d75-06ca-5c2a-e063-6394a90ad9662026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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