FDA.reportPublic FDA data

NDC 70518-4271-00 - 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
70518-4271
Requested NDC
70518-4271-00
Package NDCs from labels
70518-4271-1, 70518-4271-0, 70518-4271-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PredniSONE Tablets, USPREMEDYREPACK INC.2026-09-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4271-0PredniSONE100 in 1 BOXTABLET1003
70518-4271-1PredniSONE1 in 1 POUCHTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4271PREDNISONE TABLET [REMEDYREPACK INC.]1Current NDC, 2 package rows20250206_7db793b4-5768-4e9a-a47b-1ebbfed74001.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 1 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEBryant Ranch Prepack290a91e5-22ae-4d62-ab34-39a3117002e22026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.4750028a-30ad-420a-8e6b-06dc2429d4332026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack0062fcc7-aa08-4990-9d33-d798725907f12026-09-08Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PredniSONEPREDNISONEREMEDYREPACK INC.7db793b4-5768-4e9a-a47b-1ebbfed740012026-09-03Warnings, Adverse reactionsExact identifier
application number: ANDA080352
ndc (package): 70518-4271-0
ndc (package): 70518-4271-1
ndc (product): 70518-4271
ndc11 (package): 70518427100
rxcui: 312617
spl id: 5a942308-9d43-dc51-e063-6394a90a135e
spl set id: 7db793b4-5768-4e9a-a47b-1ebbfed74001
unii: VB0R961HZT
PREDNISONEPREDNISONEREMEDYREPACK INC.0993b354-d936-472b-bafc-114f0f81bfb02026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PredniSONEPREDNISONEREMEDYREPACK INC.94715919-70bd-46c9-95fc-e151adf39cf92026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.23b12d22-97d6-426e-bf9c-dd6c2ff773702026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.6b360c1f-c862-47ee-a40e-3903c2d6162f2026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PredniSONEPREDNISONEPreferred Pharmaceuticals Inc.02158832-550b-4855-a5c5-6abbf13ed6f02026-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA080352
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepackc60a07f9-ed9f-4434-a69d-2e2fea4843fd2026-08-20Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEREMEDYREPACK INC.746b0bcd-122e-4ea8-a824-28415073a38e2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack7ea7f6a9-78ef-42fe-baac-f817da3976fb2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEPreferred Pharmaceuticals Inc.1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
prednisonePREDNISONEPreferred Pharmaceuticals Inc.fa75f5ce-8a74-4873-811f-7d9d9beec08f2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEPreferred Pharmaceuticals Inc.930b5eea-3ec8-47df-a76d-1e0bc0b5c5b22026-08-19Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEPreferred Pharmaceuticals, Inc.f89bd1dc-88cd-4aef-a7ae-6310f38a34232026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 312617
unii: VB0R961HZT
PrednisonePREDNISONEMajor Pharmaceuticals57b98930-92ab-4b77-a033-ae9895ee718a2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEPreferred Pharmaceuticals Inc.ce7663a7-4c91-4790-aa43-96f259b3bb182026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.e47a0448-331f-4846-8e63-c52c3afa274b2026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONECardinal Health 107, LLC568b8880-7997-4786-8c57-28816ce526552026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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