FDA.reportPublic FDA data

NDC 70518-4191-01 - 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
70518-4191
Requested NDC
70518-4191-01
Package NDCs from labels
70518-4191-0, 70518-4191-1, 70518-4191-2, 70518-4191-3, 70518-4191-4, 70518-4191-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PredniSONE Tablets, USPREMEDYREPACK INC.2026-08-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4191-0PredniSONE14 in 1 BOTTLE, PLASTICTABLET146
70518-4191-1PredniSONE30 in 1 BOTTLE, PLASTICTABLET306
70518-4191-2PredniSONE20 in 1 BOTTLE, PLASTICTABLET206
70518-4191-3PredniSONE10 in 1 BOTTLE, PLASTICTABLET106
70518-4191-4PredniSONE18 in 1 BOTTLE, PLASTICTABLET186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4191PREDNISONE TABLET [REMEDYREPACK INC.]4Current NDC, 5 package rows20250418_94715919-70bd-46c9-95fc-e151adf39cf9.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 9 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PredniSONEPREDNISONEHikma Pharmaceuticals USA Inc.263ed4fa-3c29-4abb-9cb1-bc016bd34a052025-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA080352
ndc (product): 0054-9817
rxcui: 198145
rxcui: 312615
rxcui: 312617
spl id: 249c4c6d-a058-489a-8f84-928c14bfd3f9
spl set id: 263ed4fa-3c29-4abb-9cb1-bc016bd34a05
unii: VB0R961HZT
PredniSONEPREDNISONEHikma Pharmaceuticals USA Inc.3115aef0-fd50-4ec8-a064-3effb695f3f22025-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 198145
rxcui: 312615
rxcui: 312617
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
PrednisonePREDNISONENuCare Pharmaceuticals, Inc.31cfc21f-726b-ae80-e063-6294a90a9af42025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEProficient Rx LPc2f477da-0b99-4fc4-89ca-94831de950a32025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEBryant Ranch Prepack9a2d3bee-610b-44dc-8266-869aaf08f0d12025-03-27Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLC309580a7-c3bb-e53b-e063-6394a90a15632025-03-17Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
prednisonePREDNISONEBryant Ranch Prepackf0354431-4968-4e34-969b-6985d73700a42025-02-25Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEA-S Medication Solutions1cb252f0-fd01-4620-bf88-2108fc1ea6152025-02-19Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEGolden State Medical Supply, Inc.1e05e071-0407-0970-e063-6294a90a6c652025-02-18Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
PredniSONEPREDNISONEAdvanced Rx of Tennessee, LLC2e62cf2e-dcbe-c15e-e063-6294a90a81682025-02-17Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 312617
unii: VB0R961HZT
PREDNISONEPREDNISONEAdvanced Rx of Tennessee, LLC2e62cf2e-dcbf-c15e-e063-6294a90a81682025-02-17Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PredniSONEPREDNISONEAdvanced Rx of Tennessee, LLC2e630aa1-eccd-f5eb-e063-6294a90a47452025-02-17Warnings, Adverse reactionsExact identifier
application number: ANDA084122
application number: ANDA080352
rxcui: 198145
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONECoupler LLC2d99223a-853a-7640-e063-6394a90a260a2025-02-07Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PREDNISONEPREDNISONEPreferred Pharmaceuticals Inc.94d82acb-ff31-492f-bd51-b23e15d881d62025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEDirect_Rxfd8eb82e-52df-c368-e053-6294a90ac6b02025-01-22Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLCaf863b9e-964b-3b1e-e053-2995a90ab93a2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEAdvanced Rx of Tennessee, LLCaf861c38-3293-13fe-e053-2995a90a99322024-12-31Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 312617
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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