Home NDC 71205-089 Prednisone
Product NDC 71205-089
11-digit product format 712050089
Labeler code 71205
Product ID 71205-089_f37da7b3-fa10-473c-acab-371529fee8c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA040611
Marketing category ANDA
Marketing start 2005-06-06
Substance PREDNISONE
Active strength 1 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 · 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 A040611-001 PREDNISONE PREDNISONE 1MG TABLET / ORAL AB 2005-06-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040611-001 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 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040611-001 PREDNISONE 1MG TABLET / ORAL AB 2005-06-06 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 1 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 198144 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-089 PREDNISONE TABLET [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 17 package rows 20191029_7a92b171-52ca-4948-81fc-e9a30597c5d8.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 Marketing end Sample Exclude flag Status 71205-089-00 71205008900 100 TABLET in 1 BOTTLE (71205-089-00) 100 tablet 2018-08-01 0000-00-00 No No Current 71205-089-05 71205008905 5 TABLET in 1 BOTTLE (71205-089-05) 5 tablet 2018-08-01 0000-00-00 No No Current 71205-089-06 71205008906 6 TABLET in 1 BOTTLE (71205-089-06) 6 tablet 2018-08-01 0000-00-00 No No Current 71205-089-07 71205008907 7 TABLET in 1 BOTTLE (71205-089-07) 7 tablet 2018-08-01 0000-00-00 No No Current 71205-089-08 71205008908 8 TABLET in 1 BOTTLE (71205-089-08) 8 tablet 2018-08-01 0000-00-00 No No Current 71205-089-10 71205008910 10 TABLET in 1 BOTTLE (71205-089-10) 10 tablet 2018-08-01 0000-00-00 No No Current 71205-089-12 71205008912 12 TABLET in 1 BOTTLE (71205-089-12) 12 tablet 2018-08-01 0000-00-00 No No Current 71205-089-15 71205008915 15 TABLET in 1 BOTTLE (71205-089-15) 15 tablet 2018-08-01 0000-00-00 No No Current 71205-089-18 71205008918 18 TABLET in 1 BOTTLE (71205-089-18) 18 tablet 2018-08-01 0000-00-00 No No Current 71205-089-20 71205008920 20 TABLET in 1 BOTTLE (71205-089-20) 20 tablet 2018-08-01 0000-00-00 No No Current 71205-089-21 71205008921 21 TABLET in 1 BOTTLE (71205-089-21) 21 tablet 2018-08-01 0000-00-00 No No Current 71205-089-24 71205008924 24 TABLET in 1 BOTTLE (71205-089-24) 24 tablet 2018-08-01 0000-00-00 No No Current 71205-089-27 71205008927 27 TABLET in 1 BOTTLE (71205-089-27) 27 tablet 2018-08-01 0000-00-00 No No Current 71205-089-30 71205008930 30 TABLET in 1 BOTTLE (71205-089-30) 30 tablet 2018-08-01 0000-00-00 No No Current 71205-089-36 71205008936 36 TABLET in 1 BOTTLE (71205-089-36) 36 tablet 2018-08-01 0000-00-00 No No Current 71205-089-40 71205008940 40 TABLET in 1 BOTTLE (71205-089-40) 40 tablet 2018-08-01 0000-00-00 No No Current 71205-089-42 71205008942 42 TABLET in 1 BOTTLE (71205-089-42) 42 tablet 2018-08-01 0000-00-00 No No Current