RAYOS

Product NDC
75987-021
11-digit product format
759870021
Labeler code
75987
Product ID
75987-021_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
2 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75987-021-01EA - Each75987-0213acf9d71-d2b1-4ccb-b19c-0ba1f9ee105a12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75987-021RAYOS (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
75987-021-01759870021011 BOTTLE in 1 CARTON (75987-021-01) > 30 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2012-07-270000-00-00NoNoCurrent
75987-021-02759870021021 BOTTLE in 1 CARTON (75987-021-02) > 100 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2012-07-270000-00-00NoNoCurrent
75987-021-70759870021701 BOTTLE in 1 CARTON (75987-021-70) > 7 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2012-07-270000-00-00NoNoCurrent