FDA.reportPublic FDA data

NDC 80425-0231-01 - Methylprednisolone

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
80425-0231
Requested NDC
80425-0231-01
Package NDCs from labels
80425-0231-1, 80425-0231-01
Manufacturer
Advanced Rx Pharmacy 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
Methylprednisolone - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0231-1Methylprednisolone1 in 1 CARTONTABLET13
80425-0231-1Methylprednisolone21 in 1 BLISTER PACKTABLET213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0231METHYLPREDNISOLONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 2 package rows20250102_f19f6120-3c25-2a28-e053-2a95a90a86d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0231-1EA - Each80425-0231f7a54d7f-e2ea-4100-8f0e-0f27c3aa3f3b12023-04-07

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethylprednisoloneMETHYLPREDNISOLONEAdvanced Rx Pharmacy of Tennessee, LLCf19f6120-3c25-2a28-e053-2a95a90a86d52024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA206751
ndc (package): 80425-0231-1
ndc (product): 80425-0231
ndc11 (package): 80425023101
rxcui: 259966
rxcui: 762675
spl id: 2a9aec09-6307-2252-e063-6294a90a204a
spl set id: f19f6120-3c25-2a28-e053-2a95a90a86d5
unii: X4W7ZR7023
MethylprednisoloneMETHYLPREDNISOLONEAdvanced Rx Pharmacy of Tennessee, LLCf19f4304-bf37-da04-e053-2a95a90a40442024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
MethylprednisoloneMETHYLPREDNISOLONEAdvanced Rx Pharmacy of Tennessee, LLCf19f3676-856f-e8d7-e053-2995a90ad7032024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
methylprednisoloneMETHYLPREDNISOLONEZydus Lifesciences Limitedfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee2024-12-05Exact identifier
application number: ANDA206751
rxcui: 328161
rxcui: 259966
rxcui: 197971
rxcui: 197973
unii: X4W7ZR7023
MethylprednisoloneMETHYLPREDNISOLONEA-S Medication Solutionseb479561-142d-410c-84b2-988375c6a96e2024-10-02Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
MethylprednisoloneMETHYLPREDNISOLONEChartwell RX, LLCbdd048bb-7e6c-45c7-b51a-075e83ca9f5b2024-09-17Warnings, Adverse reactionsExact identifier
rxcui: 328161
rxcui: 259966
rxcui: 197971
rxcui: 197973
unii: X4W7ZR7023
METHYLPREDNISOLONEMETHYLPREDNISOLONENuCare Pharmaceuticals,Inc.a1dae00d-1ad3-7493-e053-2a95a90af49f2024-06-20Warnings, Adverse reactionsExact identifier
rxcui: 259966
unii: X4W7ZR7023
MethylPREDNISoloneMETHYLPREDNISOLONEBryant Ranch Prepack01f0126c-da22-4ac0-8755-3bc589602e6a2024-04-12Warnings, Adverse reactionsExact identifier
rxcui: 259966
unii: X4W7ZR7023
MethylPREDNISoloneMETHYLPREDNISOLONEBryant Ranch Prepackcbe5f72a-b0fb-4abb-abfe-2f917d351a002023-09-26Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
methylprednisoloneMETHYLPREDNISOLONEProficient Rx LP177fd649-4339-4bfd-bd12-7e8de302412b2023-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA206751
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
MethylPREDNISoloneMETHYLPREDNISOLONEBryant Ranch Prepack56c24076-3d5e-4235-a787-ec63294970842023-08-11Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
MethylprednisoloneMETHYLPREDNISOLONEProficient Rx LP283a913e-f737-478e-b6a0-e050fb6562d82023-07-01Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
MethylprednisoloneMETHYLPREDNISOLONEAsclemed USA, Inc.8bfdc471-54f7-4298-ba2f-e5c1f6c484562022-10-12Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
METHYLPREDNISOLONEMETHYLPREDNISOLONEProficient Rx LP3e37236f-8ba8-4a1c-87c8-62b787890fae2022-03-01Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023
METHYLPREDNISOLONEMETHYLPREDNISOLONEDoc Rxc6ec50b5-aeb8-40c3-83e2-af4fe8fefb142021-06-11Warnings, Adverse reactionsExact identifier
rxcui: 259966
unii: X4W7ZR7023
METHYLPREDNISOLONEMETHYLPREDNISOLONEAsclemed USA, Inc.8bff5330-c1f6-4014-aadb-45c1726248dd2021-03-16Warnings, Adverse reactionsExact identifier
rxcui: 259966
rxcui: 762675
unii: X4W7ZR7023

Reported adverse events (FAERS/openFDA)#

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