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 12 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISONEPREDNISONEAurobindo Pharma Limitedb1ac4c92-e1fd-4015-b172-0932790ae0192024-02-16Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONENuCare Pharmaceuticals,Inc.63102d75-9b2b-84a9-e053-2a91aa0a317d2024-02-09Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions410988ea-456a-454e-932c-fcbdbef04ba92024-01-18Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutions44069d49-4cf4-4f1e-9fbd-b496c6ca81a12024-01-18Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEA-S Medication Solutions17278e0a-cbff-4a95-96ee-f34f7466faa02023-11-24Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEChartwell RX, LLC92483276-d55c-42c6-8bbc-27137ff252962023-09-06Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
prednisonePREDNISONEProficient Rx LP6a0c1192-8ce4-466d-a0f3-d878d67349cf2023-09-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP5961b1d4-6a4c-452f-b3f1-c99f3a9a64452023-09-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PredniSONEPREDNISONEA-S Medication Solutions0060b86b-0b79-4c54-a7be-97683a933a052023-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 312617
unii: VB0R961HZT
PredniSONEPREDNISONEA-S Medication Solutionsf11c190e-edf8-454d-82c4-1ed769b5a6d22023-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 312617
unii: VB0R961HZT
PredniSONEPREDNISONEA-S Medication Solutions6f0719a2-1759-4354-9363-bb9fb3bddb3d2023-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEProficient Rx LP6ec5b58c-65e9-47ee-b2ac-7d0b395a06302023-07-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEProficient Rx LP22d9fd96-cad5-4762-9a56-0ff63357ed9e2023-02-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
prednisonePREDNISONENCS HealthCare of KY, LLC dba Vangard Labsbc37cc2e-2f6a-4131-bb6a-63b6e576df212022-11-11Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONENCS HealthCare of KY, LLC dba Vangard Labs202f6840-f3bd-4bed-ab5d-b36d3c4cdf0f2022-11-10Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEPharmPak, Inc.03aaf69f-d9c7-433c-baea-9c6eca0fe1e52022-10-08Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP71d70ec6-859a-4951-af98-248a864e11352022-09-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PredniSONEPREDNISONEProficient Rx LPe109f428-ca85-4a2c-acd0-ca8d498e77232022-06-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LP67681e4e-3002-4428-af5e-6ff1a950b0372022-05-02Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEProficient Rx LPa1bff575-cd79-4596-99f1-30a5fe8a8b4c2022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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