Home NDC 71329-107 PREDNISONE
Product NDC 71329-107
11-digit product format 713290107
Labeler code 71329
Product ID 71329-107_eafa4fdb-e631-4080-b850-a7e40866f250
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prednisone
Dosage form TABLET
Route ORAL
Labeler GeneYork Pharmaceuticals Group LLC
Application ANDA211495
Marketing category ANDA
Marketing start 2018-12-11
Marketing end 0000-00-00
Substance PREDNISONE
Active strength 3 mg/1
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71329-107-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71329-107-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71329-107-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71329-107-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71329-107-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 71329-107-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 71329-107-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71329-107-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71329-107-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 71329-107-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 71329-107-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71329-107-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 71329-107-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…
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.
Product history page 1 of 2 · 42 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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211495-001 PREDNISONE 2.5MG TABLET / ORAL 2018-12-07 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A211495-002 PREDNISONE 5MG TABLET / ORAL 2018-12-07 ea99ee380514…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211495-001 PREDNISONE 2.5MG TABLET / ORAL AB 2018-12-07 e64feba35796…2022-09-29 23:25 UTC 2022-09 A211495-002 PREDNISONE 5MG TABLET / ORAL AB 2018-12-07 e64feba35796…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71329-107-01 71329010701 1 BOTTLE in 1 CARTON (71329-107-01) > 100 TABLET in 1 BOTTLE 1 bottle 2018-12-11 0000-00-00 No No Current