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 3 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.15230866-f547-47bf-ac7d-19afd6a41e2e2026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PredniSONE Tablets, USP, 10 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.bb32e309-e3c7-4009-bcd4-d97545b7e9752026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutionsaaaa3460-0239-4203-857f-0ada303c21082026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
prednisonePREDNISONEBryant Ranch Prepackecc48869-3812-4440-a398-749b280620592026-05-29Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEBryant Ranch Prepack07d5e455-ac3b-4890-9619-609dd0be91062026-05-29Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
prednisonePREDNISONEAmerican Health Packagingfdcd49a6-6cb1-49f8-9f4c-feb475c129b32026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA208412
unii: VB0R961HZT
prednisonePREDNISONECardinal Health 107, LLC1d797f3e-a46c-42bc-91bb-c570ae8ca8c22026-05-20Warnings, Adverse reactionsExact identifier
application number: ANDA208412
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.ea4070e1-080d-4feb-9561-3910c6b712dd2026-05-15Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198145
unii: VB0R961HZT
PREDNISONEPREDNISONEST. MARY'S MEDICAL PARK PHARMACY42e0decc-4d11-e7e6-e063-6394a90a9fcc2026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.b3b70d6f-dc44-4a54-b39b-2762f37d55752026-05-13Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEQPharma Inc11870c93-fe64-e6c9-e063-6394a90a53342026-05-11Warnings, Adverse reactionsExact identifier
application number: ANDA208412
unii: VB0R961HZT
prednisonePREDNISONEQPharma Incf795ea1d-f41a-6100-e053-6394a90a63a42026-05-11Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEA-S Medication Solutionsa6811c1f-3dad-46bb-b541-fddd2ff8e5692026-05-08Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEDirect_Rxf6051257-2144-4487-e053-2995a90a973b2026-05-05Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 312615
unii: VB0R961HZT
prednisonePREDNISONEBryant Ranch Prepackfbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c52026-05-04Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEAphena Pharma Solutions - Tennessee, LLC18818282-68aa-82e9-e063-6394a90aef542026-05-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
prednisonePREDNISONEProficient Rx LP4b37ada5-1f22-46d5-a794-fd1477c0eb9b2026-05-01Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 312615
unii: VB0R961HZT
Prednisone delayed releasePREDNISONEDr. Reddys Laboratories Inc.474974ac-9811-c9f5-4050-58e535351d002026-04-30Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepacke4c1c8c5-0aa1-4531-aa7a-8567ac8dcba82026-04-29Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PREDNISONEPREDNISONECoupler LLC50734a48-807d-cc00-e063-6294a90a4dae2026-04-27Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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