FDA.reportPublic FDA data

NDC 70518-3476-01 - 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
70518-3476
Requested NDC
70518-3476-01
Package NDCs from labels
70518-3476-0, 70518-3476-1, 70518-3476-2, 70518-3476-3, 70518-3476-4, 70518-3476-5, 70518-3476-6, 70518-3476-7, 70518-3476-8, 70518-3476-9, 70518-3476-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-30
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.2026-07-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3476-0prednisone21 in 1 BLISTER PACKTABLET2118
70518-3476-1prednisone30 in 1 BLISTER PACKTABLET3018
70518-3476-2prednisone30 in 1 BOTTLE, PLASTICTABLET3018
70518-3476-3prednisone30 in 1 BOTTLE, PLASTICTABLET3018
70518-3476-4prednisone40 in 1 BOTTLE, PLASTICTABLET4018
70518-3476-5prednisone10 in 1 BOTTLE, PLASTICTABLET1018
70518-3476-6prednisone14 in 1 BOTTLE, PLASTICTABLET1418
70518-3476-7prednisone20 in 1 BOTTLE, PLASTICTABLET2018
70518-3476-8prednisone35 in 1 BOTTLE, PLASTICTABLET3518
70518-3476-9prednisone40 in 1 BOTTLE, PLASTICTABLET4018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3476PREDNISONE TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 10 package rows20241006_5218e88b-468b-4d60-ab7e-78cca632b23a.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 2 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISONEPREDNISONEProficient Rx LPeabbefb2-21a9-4745-8021-1aac1ece7f9d2026-08-01Warnings, Adverse reactionsExact identifier
rxcui: 198148
unii: VB0R961HZT
PrednisonePREDNISONEPar Health USA, LLC10fe5a3b-84dc-4600-87c2-b80c97ce18cf2026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.5218e88b-468b-4d60-ab7e-78cca632b23a2026-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA208412
ndc (package): 70518-3476-8
ndc (package): 70518-3476-5
ndc (package): 70518-3476-6
ndc (package): 70518-3476-2
ndc (package): 70518-3476-3
ndc (package): 70518-3476-0
ndc (package): 70518-3476-1
ndc (package): 70518-3476-9
ndc (package): 70518-3476-7
ndc (package): 70518-3476-4
ndc (product): 70518-3476
ndc11 (package): 70518347601
rxcui: 198145
spl id: 57d3079c-5484-8c31-e063-6394a90aabe9
spl set id: 5218e88b-468b-4d60-ab7e-78cca632b23a
unii: VB0R961HZT
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.19fdbf9f-3a64-b9fa-e063-6394a90af0862026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1a9f00ac-ec92-4d2c-e063-6394a90ac4f62026-07-29Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.25b5958b-c151-9200-e063-6394a90af52c2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1349a022-639b-4494-99a2-1594c7c0f0e92026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.288ecb6d-3b0b-db95-e063-6394a90a78ff2026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONECardinal Health 107, LLCcdc2b903-5d86-45c1-b97c-2da48445dbdd2026-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack6c0376c4-87cf-40dc-b140-a6aac75b64f72026-07-13Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack931171e2-0bdb-451e-b737-72ce3ffbed532026-07-13Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEBryant Ranch Prepack55aedced-d945-4bd2-9aa8-0f18b89a0e7f2026-07-13Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
PrednisonePREDNISONEANI Pharmaceuticals, Inc.f05eb734-07e7-491c-b2e9-aae340e037502026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 198148
unii: VB0R961HZT
prednisonePREDNISONEUnit Dose Solutions, Inc.5590d36d-dbe7-1c78-e063-6294a90ad2d42026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONEAmneal Pharmaceuticals NY LLC03228706-92b9-43c9-8d73-c73aa124c58d2026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
unii: VB0R961HZT
PredniSONEPREDNISONESt. Mary's Medical Park Pharmacy16ee689e-c7a9-3a5a-e063-6394a90a6ea22026-06-22Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONESt. Mary's Medical Park Pharmacy1b3ea4cc-5bc6-ae47-e063-6294a90af13d2026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 312615
unii: VB0R961HZT
PrednisonePREDNISONERedpharm Drug5407a00b-1bfb-e37d-e063-6294a90a6c412026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 198145
unii: VB0R961HZT
prednisonePREDNISONECoupler LLC53864d75-06ca-5c2a-e063-6394a90ad9662026-06-05Warnings, Adverse reactionsExact identifier
application number: ANDA208412
rxcui: 198148
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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