FDA.reportPublic FDA data

NDC 80425-0068-01 - 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
80425-0068
Requested NDC
80425-0068-01
Package NDCs from labels
80425-0068-1, 80425-0068-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
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, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0068-1Prednisone21 in 1 BOTTLETABLET215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0068PREDNISONE TABLET [ADVANCED RX OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 1 package rows20250101_af861c38-3293-13fe-e053-2995a90a9932.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0068-1EA - Each80425-0068fb1db9b6-4cff-41e3-9885-acecb9f7966112023-06-06

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 8 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PredniSONE Tablets, USP, 5 mgPREDNISONEBryant Ranch Prepack419058f7-7f30-41a1-964b-8eaa69290dea2025-10-03Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepackb42adc18-21cc-4fe0-bf7d-fb76f4cda2152025-10-03Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepackbfcc98b8-184e-4db4-8079-de88958c774b2025-09-26Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PredniSONE Tablets, USP, 10 mgPREDNISONEBryant Ranch Prepackaba52f0c-0706-46ac-957d-e53963d354992025-09-26Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONECoupler LLC3e0e3e28-e6ff-7b48-e063-6294a90a9acd2025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PredniSONE Tablets, USP, 5 mgPREDNISONEGranulation Technology, Inc.a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f2025-08-15Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
PREDNISONEPREDNISONEPreferred Pharmaceuticals Inc.28130e6d-7cda-459a-9f80-cacaa82d71d32025-08-01Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf2025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONEPREDNISONEPD-Rx Pharmaceuticals, Inc.f4500eb6-d24a-4247-83f4-99e73346e3282025-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutionsdc94273f-af06-4bd5-9ce3-ce0a0f36587b2025-07-03Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.27d8dcad-a024-ed85-e063-6394a90a420d2025-06-20Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONE Tablets, USP, 10 mgPREDNISONEBryant Ranch Prepack136b98cd-60aa-4dc3-966c-488f4b7d61172025-05-05Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepack48ee895b-dc3a-4f1f-8688-e06c217f449b2025-05-05Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP08973b30-8576-4d31-aeef-934b72124e1f2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PREDNISONEPREDNISONEPreferred Pharmaceuticals Inc.60bb6698-d1fc-4720-9954-266a3d650f0d2025-04-29Warnings, Adverse reactionsExact identifier
rxcui: 198146
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack0b2c2085-c4da-4441-ae5e-eefe26fd199e2025-04-25Warnings, Adverse reactionsExact identifier
rxcui: 198144
unii: VB0R961HZT
PredniSONEPREDNISONEHikma Pharmaceuticals USA Inc.263ed4fa-3c29-4abb-9cb1-bc016bd34a052025-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
PredniSONEPREDNISONEHikma Pharmaceuticals USA Inc.3115aef0-fd50-4ec8-a064-3effb695f3f22025-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA080352
ndc (product): 0054-4728
rxcui: 198145
rxcui: 198144
rxcui: 198146
rxcui: 315187
rxcui: 312615
rxcui: 198148
rxcui: 205301
rxcui: 312617
spl id: 523ad364-8d95-4679-9290-446d61f36eb5
spl set id: 3115aef0-fd50-4ec8-a064-3effb695f3f2
unii: VB0R961HZT
prednisonePREDNISONEAdvanced Rx of Tennessee, LLC2d0562ad-6175-833c-e063-6394a90ad0292025-04-04Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLC30956dd5-fe19-d5a9-e063-6394a90a25492025-04-04Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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