Home NDC 33261-129 Prednisone
Product NDC 33261-129
11-digit product format 332610129
Labeler code 33261
Product ID 33261-129_3c78a73d-80ef-4a71-8aeb-a101196947e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
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 2019-12-31
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 6 · 315 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 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…2022-10-28 04:53 UTC 2022-10 A040392-001 PREDNISONE 20MG TABLET / ORAL AB 2003-02-12 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 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, Related label table NDC Related label 33261-129-00 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-10 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-12 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-15 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-20 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-21 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-27 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-30 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-40 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-42 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-48 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-50 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-60 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg 33261-129-90 PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33261-129-00 Prednisone 100 in 1 BOTTLE, PLASTIC TABLET 100 2 33261-129-10 Prednisone 10 in 1 BOTTLE, PLASTIC TABLET 10 2 33261-129-12 Prednisone 12 in 1 BOTTLE, PLASTIC TABLET 12 2 33261-129-15 Prednisone 15 in 1 BOTTLE, PLASTIC TABLET 15 2 33261-129-20 Prednisone 20 in 1 BOTTLE, PLASTIC TABLET 20 2 33261-129-21 Prednisone 21 in 1 BOTTLE, PLASTIC TABLET 21 2 33261-129-27 Prednisone 27 in 1 BOTTLE, PLASTIC TABLET 27 2 33261-129-30 Prednisone 30 in 1 BOTTLE, PLASTIC TABLET 30 2 33261-129-40 Prednisone 40 in 1 BOTTLE, PLASTIC TABLET 40 2 33261-129-42 Prednisone 42 in 1 BOTTLE, PLASTIC TABLET 42 2 33261-129-48 Prednisone 48 in 1 BOTTLE, PLASTIC TABLET 48 2 33261-129-50 Prednisone 50 in 1 BOTTLE, PLASTIC TABLET 50 2 33261-129-60 Prednisone 60 in 1 BOTTLE, PLASTIC TABLET 60 2 33261-129-90 Prednisone 90 in 1 BOTTLE, PLASTIC TABLET 90 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-129 PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC] 2 Legacy NDC, 14 package rows 20140402_3d2eb1e3-fc2b-4820-abc6-cae1228df4c2.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33261-129-00 33261012900 100 in 1 BOTTLE, PLASTIC Historical 33261-129-10 33261012910 10 in 1 BOTTLE, PLASTIC Historical 33261-129-12 33261012912 12 in 1 BOTTLE, PLASTIC Historical 33261-129-15 33261012915 15 in 1 BOTTLE, PLASTIC Historical 33261-129-20 33261012920 20 in 1 BOTTLE, PLASTIC Historical 33261-129-21 33261012921 21 in 1 BOTTLE, PLASTIC Historical 33261-129-27 33261012927 27 in 1 BOTTLE, PLASTIC Historical 33261-129-30 33261012930 30 in 1 BOTTLE, PLASTIC Historical 33261-129-40 33261012940 40 in 1 BOTTLE, PLASTIC Historical 33261-129-42 33261012942 42 in 1 BOTTLE, PLASTIC Historical 33261-129-48 33261012948 48 in 1 BOTTLE, PLASTIC Historical 33261-129-50 33261012950 50 in 1 BOTTLE, PLASTIC Historical 33261-129-60 33261012960 60 in 1 BOTTLE, PLASTIC Historical 33261-129-90 33261012990 90 in 1 BOTTLE, PLASTIC Historical