Home NDC 50090-1990 Prednisone
Product NDC 50090-1990
11-digit product format 500901990
Labeler code 50090
Product ID 50090-1990_b62edc03-cced-412d-8452-7c8018e66d3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA040392
Marketing category ANDA
Marketing start 2003-02-12
Marketing end 0000-00-00
Substance PREDNISONE
Active strength 20 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 2 · 78 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040392-001 PREDNISONE PREDNISONE 20MG TABLET / ORAL AB 2003-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040392-001 AB
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.
Product history page 1 of 2 · 44 observed 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 2026-10-15 13:18:30 2026-09 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A040392-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040392-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040392-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A040392-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 50090-1990-0 2024-05-24 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-1 2024-05-24 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-2 2024-05-24 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-5 2024-05-24 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-7 2024-05-24 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-0 2023-01-30 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-1 2023-01-30 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-2 2023-01-30 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-5 2023-01-30 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only 50090-1990-7 2023-01-30 PredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1990 PREDNISONE TABLET [A-S MEDICATION SOLUTIONS] 16 Legacy NDC, 5 package rows 20240525_efe0c82b-9dd9-4729-b06f-06307867aca0.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 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-1990-0 50090199000 20 in 1 BOTTLE Historical 50090-1990-1 50090199001 12 in 1 BOTTLE Historical 50090-1990-2 50090199002 6 in 1 BOTTLE Historical 50090-1990-5 50090199005 14 TABLET in 1 BOTTLE (50090-1990-5) 14 tablet 2015-09-17 0000-00-00 No No Current 50090-1990-7 50090199007 15 TABLET in 1 BOTTLE (50090-1990-7) 15 tablet 2015-09-17 0000-00-00 No No Current