PREDNISONE

Product NDC
71329-106
11-digit product format
713290106
Labeler code
71329
Product ID
71329-106_4384c1d1-059b-4689-9f3d-1078de814ce8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
GeneYork Pharmaceuticals Group LLC
Application
ANDA211496
Marketing category
ANDA
Marketing start
2019-01-04
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
1 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71329-106DDiscontinued by firm2026-08-07
excluded packagepackage71329-10671329-106-01DDiscontinued by firm2026-08-07
excluded packagepackage71329-10671329-106-02DDiscontinued by firm2026-08-07

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 · 39 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71329-106-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71329-106-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71329-106-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71329-106-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71329-106-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71329-106-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71329-106-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71329-106-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71329-106-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71329-106-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71329-106-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71329-106-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71329-106-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71329-106-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71329-106-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71329-106-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71329-106-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71329-106-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71329-106-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71329-106-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71329-106-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71329-106-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71329-106-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71329-106-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage71329-106-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage71329-106-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211496-001PREDNISONEPREDNISONE1MGTABLET / ORAL2018-12-28

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211496-001PREDNISONE1MGTABLET / ORAL2018-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211496-001PREDNISONE1MGTABLET / ORAL2018-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211496-001PREDNISONE1MGTABLET / ORAL2018-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211496-001PREDNISONE1MGTABLET / ORAL2018-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211496-001PREDNISONE1MGTABLET / ORAL2018-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211496-001PREDNISONE1MGTABLET / ORAL2018-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211496-001PREDNISONE1MGTABLET / ORAL2018-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211496-001PREDNISONE1MGTABLET / ORAL2018-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211496-001PREDNISONE1MGTABLET / ORAL2018-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211496-001PREDNISONE1MGTABLET / ORAL2018-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211496-001PREDNISONE1MGTABLET / ORAL2018-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211496-001PREDNISONE1MGTABLET / ORAL2018-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211496-001PREDNISONE1MGTABLET / ORAL2018-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211496-001PREDNISONE1MGTABLET / ORAL2018-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-283f01610625f2…
2019-09-15 20:21 UTC2019-09A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A211496-001PREDNISONE1MGTABLET / ORAL2018-12-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211496-001PREDNISONE1MGTABLET / ORAL2018-12-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211496-001PREDNISONE1MGTABLET / ORALAB2018-12-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211496-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211496-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211496-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211496-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211496-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211496-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211496-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211496-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211496-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211496-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211496-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211496-001AB1b00525d2431f…
2024-02-18 07:12 UTC2024-02A211496-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211496-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211496-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211496-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211496-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211496-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211496-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211496-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211496-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211496-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211496-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211496-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71329-106-012022-10-19PredniSONE Tablets USP
71329-106-022022-10-19PredniSONE Tablets USP
71329-106-012022-07-29PredniSONE Tablets USP
71329-106-022022-07-29PredniSONE Tablets USP

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEChartwell RX, LLCf532c919-765d-407a-9e01-db2dc0c006f52025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211496
application number: ANDA211496

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71329-106-01713290106011 BOTTLE in 1 CARTON (71329-106-01) > 1000 TABLET in 1 BOTTLE1 bottle2019-01-040000-00-00NoNoCurrent
71329-106-02713290106021 BOTTLE in 1 CARTON (71329-106-02) > 100 TABLET in 1 BOTTLE1 bottle2019-01-040000-00-00YesNoCurrent