PredniSONE

Product NDC
0463-6141
11-digit product format
004636141
Labeler code
0463
Product ID
0463-6141_7f7b221e-0c33-4295-8d8e-cec1cda84c59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
C.O. Truxton, Inc.
Application
ANDA087342
Marketing category
ANDA
Marketing start
2003-02-13
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0463-6141IInactivated by FDA2026-08-03
excluded packagepackage0463-61410463-6141-05IInactivated by FDA2026-08-03

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 · 44 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 packagepackage0463-6141-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0463-6141-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0463-6141-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0463-6141-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0463-6141-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0463-6141-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0463-6141-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0463-6141-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0463-6141-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0463-6141-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0463-6141-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0463-6141-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0463-6141-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0463-6141-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0463-6141-051332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0463-6141-05fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0463-6141-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0463-6141-05bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage0463-6141-058dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0463-6141-05e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0463-6141-059bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0463-6141-05110d247fa046…a55b01930146…

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
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087342-001PREDNISONE20MGTABLET / ORALABRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087342-001PREDNISONE20MGTABLET / ORALABRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087342-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087342-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087342-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087342-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087342-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087342-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087342-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087342-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087342-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087342-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087342-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087342-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087342-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087342-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087342-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087342-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087342-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087342-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A087342-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087342-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087342-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087342-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A087342-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087342-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087342-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087342-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087342-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087342-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087342-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087342-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087342-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087342-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087342-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087342-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087342-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087342-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087342-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0463-6141-05PredniSONE500 in 1 BOTTLE, PLASTICTABLET5002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [C.O. TRUXTON, INC.]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [C.O. TRUXTON, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [C.O. TRUXTON, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET [C.O. TRUXTON, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [C.O. TRUXTON, INC.]2
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIPREDNISONE TABLET [C.O. TRUXTON, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [C.O. TRUXTON, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [C.O. TRUXTON, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [C.O. TRUXTON, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0463-6141PREDNISONE TABLET [C.O. TRUXTON, INC.]2Legacy NDC, 1 package rows20140605_62c77974-61d4-4fe6-a6e4-0a7a1bc86e76.zip

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
PredniSONEPREDNISONENorthwind Health Company, LLCca39fdfb-d110-6535-e053-2995a90a550a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087342
application number: ANDA087342

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312617predniSONE 5 MG Oral TabletPSN62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312615prednisone 20 MG Oral TabletSCD62c77974-61d4-4fe6-a6e4-0a7a1bc86e762
312617prednisone 5 MG Oral TabletSCD62c77974-61d4-4fe6-a6e4-0a7a1bc86e762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0463-6141-0500463614105500 in 1 BOTTLE, PLASTICHistorical