PredniSONE

Product NDC
21695-580
11-digit product format
216950580
Labeler code
21695
Product ID
21695-580_5092299c-3782-4ee5-b3e7-4e80bf378e3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA087800
Marketing category
ANDA
Marketing start
1982-04-22
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
1 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 productproduct21695-580IInactivated by FDA2026-10-05
excluded packagepackage21695-58021695-580-05IInactivated by FDA2026-10-05
excluded packagepackage21695-58021695-580-14IInactivated by FDA2026-10-05

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 · 66 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 packagepackage21695-580-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-580-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-580-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-580-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-580-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-580-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-580-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-580-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-580-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-580-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-580-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-580-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-580-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-580-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-580-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-580-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-580-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-580-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-580-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-580-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-580-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-580-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-580-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-580-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-580-058af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-580-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-580-05834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-580-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-580-051332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-580-141332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-580-05fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-580-14fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-580-0586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-580-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-580-05bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-580-14bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-580-058dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-580-148dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-580-05e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-580-14e2bbac7714bc…27bdfed8d636…

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 ZIP2025-03A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087800-001PREDNISONE1MGTABLET / ORALABRS1982-04-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087800-001PREDNISONE1MGTABLET / ORALABRS1982-04-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A087800-001PREDNISONE1MGTABLET / ORALABRS1982-04-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087800-001PREDNISONE1MGTABLET / ORALABRS1982-04-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087800-001PREDNISONE1MGTABLET / ORALABRS1982-04-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087800-001PREDNISONE1MGTABLET / ORALABRS1982-04-223f01610625f2…
2019-09-15 20:21 UTC2019-09A087800-001PREDNISONE1MGTABLET / ORALABRS1982-04-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A087800-001PREDNISONE1MGTABLET / ORALABRS1982-04-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087800-001PREDNISONE1MGTABLET / ORALABRLD, RS1982-04-22cb3db0bc1861…

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 ZIP2025-03A087800-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087800-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087800-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087800-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087800-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087800-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087800-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087800-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087800-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087800-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087800-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087800-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087800-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087800-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087800-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087800-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087800-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087800-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A087800-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087800-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087800-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087800-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A087800-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087800-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087800-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087800-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087800-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087800-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087800-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087800-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087800-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087800-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087800-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087800-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087800-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087800-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087800-001AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
21695-580-052019-09-24C16284748780-1934fe258-4c4d-48b1-e053-8cdaa90a720aPredniSONE Tablets USP, 50 mg
21695-580-142019-09-24C16284748780-1934fe258-4c4d-48b1-e053-8cdaa90a720aPredniSONE Tablets USP, 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-580-05PredniSONE5 in 1 BOTTLE, PLASTICTABLET51
21695-580-14PredniSONE14 in 1 BOTTLE, PLASTICTABLET141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-580-05EA - Each21695-58062068ab5-a49f-43da-9805-4e400444d4ec12012-07-24
21695-580-14EA - Each21695-580a2eb2634-5d4b-45b4-867d-ecdcdd17fc5d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-580PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101119_5092299c-3782-4ee5-b3e7-4e80bf378e3b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-580-05216950580055 in 1 BOTTLE, PLASTICHistorical
21695-580-142169505801414 in 1 BOTTLE, PLASTICHistorical