Prednisone

Product NDC
59115-140
11-digit product format
591150140
Labeler code
59115
Product ID
59115-140_b911f5f3-484f-4103-84f4-c12158d9982b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceutical
Application
ANDA088832
Marketing category
ANDA
Marketing start
1985-12-04
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct59115-140DDiscontinued by firm2026-08-17
excluded packagepackage59115-14059115-140-01DDiscontinued by firm2026-08-17
excluded packagepackage59115-14059115-140-10DDiscontinued by firm2026-08-17

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 · 40 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59115-140-10DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59115-140-01DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage59115-140-99UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage59115-140-99UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2025-08-23 18:47 UTC2025-08A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-043f01610625f2…
2019-09-15 20:21 UTC2019-09A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088832-001PREDNISONE10MGTABLET / ORALAB1985-12-04cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A088832-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088832-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088832-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088832-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088832-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088832-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088832-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088832-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088832-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088832-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088832-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088832-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088832-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088832-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088832-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088832-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088832-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088832-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088832-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088832-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088832-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088832-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088832-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088832-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088832-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088832-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088832-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088832-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088832-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088832-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088832-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088832-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088832-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088832-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088832-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088832-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088832-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088832-001AB1cb3db0bc1861…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONENorthwind Health Company, LLCf76db82a-826e-92b0-e053-6294a90a8ec62026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088832
application number: ANDA088832
PrednisonePREDNISONEGolden State Medical Supply, Inc.1e05e071-0407-0970-e063-6294a90a6c652025-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088832
application number: ANDA088832
PrednisonePREDNISONEMylan Pharmaceuticals Inc.fec09050-5ac2-451b-a2b9-5a21b2def2122024-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088832
application number: ANDA088832