Home NDC 55154-2147-0 Prednisone
Product NDC 55154-2147
Requested package NDC 55154-2147-0
11-digit product format 551542147
Labeler code 55154
Product ID 55154-2147_cb05df8c-049d-45fe-aad8-a12af5bd36e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA040392
Marketing category ANDA
Marketing start 2025-07-09
Marketing end 2027-03-31
Substance PREDNISONE
Active strength 20 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Prednisone Active Ingredients# Ingredient, Strength table Ingredient Strength PREDNISONE 20 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-2147-0 Prednisone 1 in 1 BLISTER PACK TABLET 1 3 55154-2147-0 Prednisone 10 in 1 BAG TABLET 10 3
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 · 2 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 55154-2147-0 55154214700 10 BLISTER PACK in 1 BAG (55154-2147-0) / 1 TABLET in 1 BLISTER PACK 10 blister pack 2025-07-09 2027-03-31 No No Historical