PREDNISONE

Product NDC
71205-403
11-digit product format
712050403
Labeler code
71205
Product ID
71205-403_faad025b-3b4b-44f8-8601-f61201a543e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210525
Marketing category
ANDA
Marketing start
2018-12-04
Marketing end
2023-08-31
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71205-403DDiscontinued by firm2026-08-07
excluded packagepackage71205-40371205-403-05DDiscontinued by firm2026-08-07
excluded packagepackage71205-40371205-403-06DDiscontinued by firm2026-08-07
excluded packagepackage71205-40371205-403-07DDiscontinued by firm2026-08-07
excluded packagepackage71205-40371205-403-10DDiscontinued by firm2026-08-07
excluded packagepackage71205-40371205-403-12DDiscontinued by firm2026-08-07
excluded packagepackage71205-40371205-403-30DDiscontinued by firm2026-08-07
excluded packagepackage71205-40371205-403-60DDiscontinued by firm2026-08-07
excluded packagepackage71205-40371205-403-90DDiscontinued 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 · 108 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 packagepackage71205-403-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-403-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-403-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-403-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-403-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-403-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-403-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71205-403-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-403-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-403-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-403-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-403-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-403-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-403-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-403-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71205-403-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-403-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-403-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-403-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-403-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-403-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-403-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-403-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71205-403-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-403-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-403-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-403-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-403-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-403-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-403-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-403-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71205-403-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-403-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-403-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-403-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-403-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-403-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-403-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-403-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71205-403-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-403-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-403-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-403-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-403-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-403-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-403-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-403-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71205-403-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71205-403-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71205-403-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71205-403-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71205-403-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71205-403-30302b2466d912…e7b80fea0513…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-403-05EA - Each71205-40330ea3745-04e6-4bcb-955c-e0a99327482612020-05-08
71205-403-06EA - Each71205-4037600bf03-ce68-4ee8-9783-603c198ad4db12021-10-08
71205-403-10EA - Each71205-403957b91d4-6855-40df-9544-29bbda71e9a312021-06-02
71205-403-12EA - Each71205-4031fc91c7e-35aa-49a5-a69a-cdb51bea285412020-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-403-05712050403055 TABLET in 1 BOTTLE, PLASTIC (71205-403-05) 5 tablet2020-03-190000-00-00NoNoCurrent
71205-403-06712050403066 TABLET in 1 BOTTLE, PLASTIC (71205-403-06) 6 tablet2021-08-182023-08-31NoNoCurrent
71205-403-07712050403077 TABLET in 1 BOTTLE, PLASTIC (71205-403-07) 7 tablet2020-08-130000-00-00NoNoCurrent
71205-403-107120504031010 TABLET in 1 BOTTLE, PLASTIC (71205-403-10) 10 tablet2021-04-230000-00-00NoNoCurrent
71205-403-127120504031212 TABLET in 1 BOTTLE, PLASTIC (71205-403-12) 12 tablet2020-02-172023-08-31NoNoCurrent
71205-403-307120504033030 TABLET in 1 BOTTLE, PLASTIC (71205-403-30) 30 tablet2020-02-170000-00-00NoNoCurrent
71205-403-607120504036060 TABLET in 1 BOTTLE, PLASTIC (71205-403-60) 60 tablet2020-02-170000-00-00NoNoCurrent
71205-403-907120504039090 TABLET in 1 BOTTLE, PLASTIC (71205-403-90) 90 tablet2020-02-170000-00-00NoNoCurrent