Home NDC 51655-763-52 PredniSONE
Product NDC 51655-763
Requested package NDC 51655-763-52
11-digit product format 516550763
Labeler code 51655
Product ID 51655-763_4951ac49-5bba-db7c-e063-6394a90a1d2b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PredniSONE
Dosage form TABLET
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA087801
Marketing category ANDA
Marketing start 2021-07-16
Substance PREDNISONE
Active strength 2.5 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base PredniSONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VB0R961HZT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198146 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51655-763-52 PredniSONE 30 in 1 BOTTLE, PLASTIC TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-763 PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC] 3 Current NDC, 1 package rows 20241228_da6fce58-0ef9-f3b1-e053-2995a90a1bec.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51655-763-52 51655076352 30 TABLET in 1 BOTTLE, PLASTIC (51655-763-52) 30 tablet 2021-07-16 No No Current