PREDNISONE

Product NDC
68071-5242
11-digit product format
680715242
Labeler code
68071
Product ID
68071-5242_de3466ae-481b-8b56-e053-2a95a90aabfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210525
Marketing category
ANDA
Marketing start
2018-12-04
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-5242DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-0DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-1DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-2DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-3DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-4DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-5DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-6DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-7DDiscontinued by firm2026-08-07
excluded packagepackage68071-524268071-5242-8DDiscontinued 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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-5242-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-5242-8f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-5242-82ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-5242-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-5242-8cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-5242-8cdf11ea48f46…ba0047e9e063…

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210525-001PREDNISONEPREDNISONE10MGTABLET / ORAL2018-12-04
A210525-002PREDNISONEPREDNISONE20MGTABLET / ORAL2018-12-04
A210525-003PREDNISONEPREDNISONE50MGTABLET / ORAL2018-12-04
A210525-004PREDNISONEPREDNISONE2.5MGTABLET / ORAL2018-12-07
A210525-005PREDNISONEPREDNISONE5MGTABLET / ORAL2018-12-07

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 5 · 163 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-001PREDNISONE10MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-002PREDNISONE20MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-003PREDNISONE50MGTABLET / ORAL2018-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210525-005PREDNISONE5MGTABLET / ORAL2018-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210525-001PREDNISONE10MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-002PREDNISONE20MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-003PREDNISONE50MGTABLET / ORAL2018-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210525-005PREDNISONE5MGTABLET / ORAL2018-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-001PREDNISONE10MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-002PREDNISONE20MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-003PREDNISONE50MGTABLET / ORAL2018-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210525-005PREDNISONE5MGTABLET / ORAL2018-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-001PREDNISONE10MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-002PREDNISONE20MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-003PREDNISONE50MGTABLET / ORAL2018-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210525-005PREDNISONE5MGTABLET / ORAL2018-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-001PREDNISONE10MGTABLET / ORAL2018-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-002PREDNISONE20MGTABLET / ORAL2018-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-003PREDNISONE50MGTABLET / ORAL2018-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210525-005PREDNISONE5MGTABLET / ORAL2018-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-001PREDNISONE10MGTABLET / ORAL2018-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-002PREDNISONE20MGTABLET / ORAL2018-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-003PREDNISONE50MGTABLET / ORAL2018-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-004PREDNISONE2.5MGTABLET / ORAL2018-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210525-005PREDNISONE5MGTABLET / ORAL2018-12-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210525-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210525-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210525-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210525-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210525-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210525-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210525-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210525-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210525-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210525-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210525-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210525-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210525-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210525-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210525-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210525-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210525-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210525-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210525-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210525-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210525-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A210525-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A210525-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A210525-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210525-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A210525-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A210525-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210525-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A210525-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A210525-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210525-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A210525-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A210525-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A210525-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A210525-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A210525-003AB1b00525d2431f…
2024-02-18 07:12 UTC2024-02A210525-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210525-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210525-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A210525-004AB11c564ffb4f44…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5242-22022-02-07C16284748780-1d6a99b39-d758-a426-e053-dadaa90af4c2PredniSONE Tablets, USP
68071-5242-22022-01-28C16284748780-1d6a99b39-d758-a426-e053-dadaa90af4c2PredniSONE Tablets, USP

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5242-06807152420010 TABLET in 1 BOTTLE (68071-5242-0) 10 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-16807152420121 TABLET in 1 BOTTLE (68071-5242-1) 21 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-26807152420220 TABLET in 1 BOTTLE (68071-5242-2) 20 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-36807152420330 TABLET in 1 BOTTLE (68071-5242-3) 30 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-46807152420440 TABLET in 1 BOTTLE (68071-5242-4) 40 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-56807152420515 TABLET in 1 BOTTLE (68071-5242-5) 15 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-6680715242066 TABLET in 1 BOTTLE (68071-5242-6) 6 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-7680715242076 TABLET in 1 BOTTLE (68071-5242-7) 6 tablet2020-04-240000-00-00NoNoCurrent
68071-5242-86807152420818 TABLET in 1 BOTTLE (68071-5242-8) 18 tablet2020-04-240000-00-00NoNoCurrent