Home NDC 50090-1455-0 PredniSONE
Product NDC 50090-1455
Requested package NDC 50090-1455-0
11-digit product format 500901455
Labeler code 50090
Product ID 50090-1455_f62dd441-5ca3-4b74-b1cd-2d96cfb4f0e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PredniSONE
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA087801
Marketing category ANDA
Marketing start 1982-04-22
Marketing end 0000-00-00
Substance PREDNISONE
Active strength 3 mg/1
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1455 50090-1455-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1455 50090-1455-0 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog .
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RLD, RS 1982-04-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A087801-001 PREDNISONE 2.5MG TABLET / ORAL AB RS 1982-04-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# 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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PredniSONE PREDNISONE Northwind Health Company, LLC da6fce58-0ef9-f3b1-e053-2995a90a1bec 2026-01-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 087801 application number: ANDA087801
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-1455-0 50090145500 30 TABLET in 1 BOTTLE (50090-1455-0) 30 tablet 2014-11-28 0000-00-00 No No Current