PredniSONE

Product NDC
55695-015
11-digit product format
556950015
Labeler code
55695
Product ID
55695-015_2bd7c7c4-0fe3-2ee8-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
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
2018-12-31
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 productproduct55695-015IInactivated by FDA2026-08-03
excluded packagepackage55695-01555695-015-00IInactivated 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55695-015-00IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55695-015-00IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55695-015-00IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55695-015-00IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55695-015-00IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55695-015-00IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55695-015-00IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55695-015-00IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55695-015-00IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55695-015-00IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55695-015-00IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55695-015-00IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55695-015-00IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55695-015-00IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55695-015-00IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55695-015-00IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55695-015-00IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55695-015-00IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55695-015-00IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55695-015-00IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55695-015-00IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55695-015-00EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55695-015-002020-01-31C16284748780-19d75b9d0-b734-f424-e053-dadaa90a57cePredniSONE Tablets USP, 20 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-015-00PredniSONE100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-015PREDNISONE TABLET [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]1Legacy NDC, 1 package rows20160311_2bd7c7c4-1047-2ee8-e054-00144ff88e88.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 TabletPSN2bd7c7c4-1047-2ee8-e054-00144ff88e881
312615prednisone 20 MG Oral TabletSCD2bd7c7c4-1047-2ee8-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55695-015-0055695001500100 in 1 BOTTLE, PLASTICHistorical