Prednisone

Product NDC
21695-305
11-digit product format
216950305
Labeler code
21695
Product ID
21695-305_9fde9268-d5e8-4402-a429-df55f075861d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA080292
Marketing category
ANDA
Marketing start
1972-05-22
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
5 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 productproduct21695-305IInactivated by FDA2026-08-17
excluded packagepackage21695-30521695-305-30IInactivated by FDA2026-08-17

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 · 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 packagepackage21695-305-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-305-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-305-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-305-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-305-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-305-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-305-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-305-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-305-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-305-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-305-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-305-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-305-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-305-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-305-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-305-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-305-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-305-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-305-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-305-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-305-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-305-30110d247fa046…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
2025-08-23 18:47 UTC2025-08A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080292-001PREDNISONE5MGTABLET / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080292-001PREDNISONE5MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080292-001PREDNISONE5MGTABLET / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080292-001PREDNISONE5MGTABLET / ORALABApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080292-001PREDNISONE5MGTABLET / ORALABApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080292-001PREDNISONE5MGTABLET / ORALABApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A080292-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080292-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080292-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080292-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080292-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080292-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080292-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080292-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080292-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080292-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080292-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080292-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080292-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080292-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080292-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080292-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080292-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080292-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080292-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A080292-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080292-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080292-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080292-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A080292-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A080292-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080292-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080292-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080292-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080292-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080292-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080292-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080292-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A080292-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A080292-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080292-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080292-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080292-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080292-001AB1cb3db0bc1861…

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
21695-305-302019-09-24C16284748780-1934fe258-4cfb-48b1-e053-8cdaa90a720aPREDNISONE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-305-30Prednisone30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-305-30EA - Each21695-3059b56f922-9811-4ad3-b115-fa716c55ae4d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PrednisoneACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
PrednisoneACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UPREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-305PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101119_9fde9268-d5e8-4402-a429-df55f075861d.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONENorthwind Health Company, LLCda7f948f-8039-5f0d-e053-2a95a90ad0f02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080292
application number: ANDA080292
PrednisonePREDNISONEQPharma, Inc.c0e147a8-36a9-1e61-e053-2a95a90afd622025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080292
application number: ANDA080292
PrednisonePREDNISONEGolden State Medical Supply, Inc.1e05e071-0407-0970-e063-6294a90a6c652025-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080292
application number: ANDA080292
PrednisonePREDNISONEBryant Ranch Prepack91167f27-6f36-4b89-a530-be26209e43012024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080292
application number: ANDA080292
PrednisonePREDNISONEMylan Pharmaceuticals Inc.fec09050-5ac2-451b-a2b9-5a21b2def2122024-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080292
application number: ANDA080292

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN9fde9268-d5e8-4402-a429-df55f075861d1
312615predniSONE 20 MG Oral TabletPSN9fde9268-d5e8-4402-a429-df55f075861d1
312617predniSONE 5 MG Oral TabletPSN9fde9268-d5e8-4402-a429-df55f075861d1
198145prednisone 10 MG Oral TabletSCD9fde9268-d5e8-4402-a429-df55f075861d1
312615prednisone 20 MG Oral TabletSCD9fde9268-d5e8-4402-a429-df55f075861d1
312617prednisone 5 MG Oral TabletSCD9fde9268-d5e8-4402-a429-df55f075861d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-305-302169503053030 in 1 BOTTLEHistorical