RAYOS

Product NDC
75987-020
Requested package NDC
75987-020-70
11-digit product format
759870020
Labeler code
75987
Product ID
75987-020_96a17428-b512-4fd9-a64d-50160d22aaaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Horizon Therapeutics USA, Inc.
Application
NDA202020
Marketing category
NDA
Marketing start
2012-07-27
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
1 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage75987-02075987-020-70DDiscontinued 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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage75987-02075987-020-70DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202020-001RAYOSPREDNISONE1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26
N202020-002RAYOSPREDNISONE2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26
N202020-003RAYOSPREDNISONE5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202020-00195046992027-08-03U-13622016-12-07
N202020-00295046992027-08-03U-13622016-12-07
N202020-00395046992027-08-03U-13622016-12-07
N202020-00381682182028-01-07U-1269Drug product2012-08-22

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALABRLD, RS2012-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALRLD2012-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALABRLD, RS2012-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALABRLD, RS2012-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202020-002RAYOS2MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202020-003RAYOS5MGTABLET, DELAYED RELEASE / ORALABRLD, RS2012-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202020-001RAYOS1MGTABLET, DELAYED RELEASE / ORALABRLD2012-07-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202020-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202020-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202020-003AB15bbf6a4d5a75…
2024-10-29 15:01 UTC2024-10N202020-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N202020-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N202020-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202020-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202020-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202020-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202020-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202020-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202020-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202020-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202020-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202020-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202020-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202020-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N202020-003AB18072bd15b7f6…
2019-12-13 00:20 UTC2019-12N202020-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202020-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202020-003AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N202020-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N202020-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N202020-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N202020-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N202020-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N202020-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N202020-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N202020-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N202020-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202020-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202020-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202020-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202020-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N202020-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N202020-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202020-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N202020-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N202020-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202020-001AB1a72a2bbeb626…

Observed Orange Book patent history#

Patent history page 1 of 16 · 612 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N202020-00195046992027-08-03U-13622016-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N202020-00295046992027-08-03U-13622016-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N202020-00395046992027-08-03U-13622016-12-07caaa826d4ba7…
2026-08-18 06:07:402026-07N202020-00381682182028-01-07U-1269Drug product2012-08-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202020-00195046992027-08-03U-13622016-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202020-00295046992027-08-03U-13622016-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202020-00395046992027-08-03U-13622016-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202020-00381682182028-01-07U-1269Drug product2012-08-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202020-00195046992027-08-03U-13622016-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202020-00295046992027-08-03U-13622016-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202020-00395046992027-08-03U-13622016-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202020-00381682182028-01-07U-1269Drug product2012-08-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N202020-00195046992027-08-03U-13622016-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202020-00295046992027-08-03U-13622016-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202020-00395046992027-08-03U-13622016-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202020-00381682182028-01-07U-1269Drug product2012-08-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202020-00195046992027-08-03U-13622016-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202020-00295046992027-08-03U-13622016-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202020-00395046992027-08-03U-13622016-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202020-00381682182028-01-07U-1269Drug product2012-08-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202020-00195046992027-08-03U-13622016-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202020-00295046992027-08-03U-13622016-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202020-00395046992027-08-03U-13622016-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202020-00381682182028-01-07U-1269Drug product2012-08-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00183091242024-04-23U-12922012-11-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00183944072024-04-23U-1362Drug product2013-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00190400852024-04-23U-13622015-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00191863322024-04-23U-13622015-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00195046992027-08-03U-13622016-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00283091242024-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00283944072024-04-23U-1362Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00290400852024-04-23U-13622015-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00291863322024-04-23U-13622015-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00295046992027-08-03U-13622016-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00383091242024-04-23U-129203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00383944072024-04-23U-1362Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00390400852024-04-23U-13622015-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00391863322024-04-23U-13622015-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00395046992027-08-03U-13622016-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202020-00381682182028-01-07U-1269Drug product2012-08-2203ed91905a0d…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-020-01EA - Each75987-020f03022cc-7638-498b-93b9-a573848b2e0312013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-020RAYOS (PREDNISONE) TABLET, DELAYED RELEASE [HORIZON THERAPEUTICS USA, INC.]14Legacy NDC20240615_281ab967-7565-4bef-9c0c-a646589c671e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75987-020-70759870020701 BOTTLE in 1 CARTON (75987-020-70) > 7 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2012-07-270000-00-00NoNoCurrent