FDA.reportPublic FDA data

NDC 70518-3401-08 - 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
70518-3401
Requested NDC
70518-3401-08
Package NDCs from labels
70518-3401-0, 70518-3401-1, 70518-3401-2, 70518-3401-3, 70518-3401-4, 70518-3401-5, 70518-3401-6, 70518-3401-7, 70518-3401-8, 70518-3401-9, 70518-3401-08
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PredniSONE Tablets USP Rx onlyREMEDYREPACK INC.2026-08-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3401-0prednisone34 in 1 BOTTLE, PLASTICTABLET3417
70518-3401-1prednisone13 in 1 BOTTLE, PLASTICTABLET1317
70518-3401-2prednisone20 in 1 BOTTLE, PLASTICTABLET2017
70518-3401-3prednisone10 in 1 BOTTLE, PLASTICTABLET1017
70518-3401-4prednisone10 in 1 BLISTER PACKTABLET1017
70518-3401-5prednisone15 in 1 BOTTLE, PLASTICTABLET1517
70518-3401-6prednisone30 in 1 BOTTLE, PLASTICTABLET3017
70518-3401-7prednisone20 in 1 BOTTLE, PLASTICTABLET2017
70518-3401-8prednisone10 in 1 BOTTLE, PLASTICTABLET1017
70518-3401-9prednisone14 in 1 BOTTLE, PLASTICTABLET1417

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3401PREDNISONE TABLET [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 10 package rows20250104_af5d0f73-2aef-4db1-ae25-6d465c9f0ca1.zip

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 5 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepack852ea185-1bda-4c89-a192-ee0f93cba4282026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions71295010-5adb-499b-a03a-5c78b5e79b2d2026-03-07Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
prednisonePREDNISONEAsclemed USA, Inc.fdcf3271-fae7-47ef-a370-adbdc0a3cf372026-03-03Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198145
rxcui: 312615
rxcui: 198148
unii: VB0R961HZT
PREDNISONEPREDNISONENuCare Pharmaceuticals, Inc.2760a808-b076-5887-e063-6294a90a79ae2026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONEQPharma, Inc.4aa286e3-e272-8095-e063-6394a90ae8712026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONEASCLEMED USA INC.bf6ebe58-e7bb-49d3-842e-3372f8ba61722026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 198148
unii: VB0R961HZT
PREDNISONEPREDNISONENuCare Pharmaceuticals, Inc.292e2529-711c-7b74-e063-6394a90a660d2026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONESportpharm LLC0e3d2f62-2b02-4ddf-a983-abb71ff31e362026-02-03Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONEREMEDYREPACK INC.ab9bffed-b1a2-4e82-ac45-bee40b41060f2026-02-02Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONECardinal Health 107, LLC199ed6a6-d9d9-49de-b383-5933a026591b2026-01-27Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutionsefe0c82b-9dd9-4729-b06f-06307867aca02026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
prednisonePREDNISONECoupler LLC47bb25d2-f33c-96ce-e063-6394a90a069e2026-01-06Warnings, Adverse reactionsExact identifier
application number: ANDA208412
unii: VB0R961HZT
prednisonePREDNISONENorthwind Health Company, LLCf2a15b5d-f540-2582-e053-2995a90a591a2026-01-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONENorthwind Health Company, LLCfaf6c0c5-e5f4-4de5-e053-6294a90abd1a2026-01-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONENorthwind Health Company, LLCf6cb7924-4190-f130-e053-6294a90a21fe2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
prednisonePREDNISONENorthwind Health Company, LLCf2f1a2ea-fa1b-b4f1-e053-2995a90aa2762026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198148
unii: VB0R961HZT
PredniSONEPREDNISONENorthwind Health Company, LLCab315be2-8d13-be25-e053-2995a90a51842026-01-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONENorthwind Health Company, LLC0f377d9f-b2f4-4dae-b503-5f963bea281f2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PredniSONEPREDNISONENorthwind Health Company, LLCdad4f191-8893-48e0-e053-2995a90ae8642026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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