NDC 68071-3581-01 - 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
68071-3581
Requested NDC
68071-3581-01
Package NDCs from labels
68071-3581-1, 68071-3581-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-02-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PredniSONE Tablets, USPNuCare Pharmaceuticals,Inc.2024-02-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3581-1PredniSONE100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3581PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240302_1289c6d2-2707-baca-e063-6294a90a750d.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 · 249 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISONEPREDNISONEProficient Rx LPeabbefb2-21a9-4745-8021-1aac1ece7f9d2026-08-01Warnings, Adverse reactionsExact identifier
unii: VB0R961HZT
PrednisonePREDNISONEPar Health USA, LLC10fe5a3b-84dc-4600-87c2-b80c97ce18cf2026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 198145
rxcui: 312615
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONEREMEDYREPACK INC.5218e88b-468b-4d60-ab7e-78cca632b23a2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 198145
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
rxcui: 312617
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
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
rxcui: 312617
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: 312617
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
application number: ANDA080352
rxcui: 312617
unii: VB0R961HZT
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsExact identifier
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
unii: VB0R961HZT

Reported adverse events (FAERS/openFDA)#

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