Home NDC 66336-219 PredniSONE
Product NDC 66336-219
11-digit product format 663360219
Labeler code 66336
Product ID 66336-219_ce688852-a790-4180-92db-b83cbdab8c3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PredniSONE
Dosage form TABLET
Route ORAL
Labeler Dispensing Solutions, Inc.
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 E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66336-219-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66336-219-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66336-219-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66336-219-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66336-219-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66336-219-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66336-219-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66336-219-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66336-219-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66336-219-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66336-219-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66336-219-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 66336-219-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 66336-219-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 66336-219-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66336-219-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66336-219-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66336-219-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66336-219-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66336-219-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66336-219-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66336-219-30 110d247fa046…a55b01930146…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 66336-219-30 2019-11-27 C162847 48780-1 9855d018-e33f-cd31-e053-dbdaa90ab51a PredniSONE Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg, PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66336-219-30 PredniSONE 30 in 1 BOTTLE, PLASTIC TABLET 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PREDNISONE ACTIVE INGREDIENT VB0R961HZT PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1 PREDNISONE ACTIVE MOIETY VB0R961HZT PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66336-219 PREDNISONE TABLET [DISPENSING SOLUTIONS, INC.] 1 Legacy NDC, 1 package rows 20130619_43bbc0a1-386f-480e-9df4-8bc60630c66e.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.
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 66336-219-30 66336021930 30 in 1 BOTTLE, PLASTIC Historical