RAYOS
These highlights do not include all the information needed to use RAYOS safely and effectively. See full prescribing information for RAYOS. RAYOS (prednisone) delayed-release tablets 1 mg, 2 mg, 5 mg Initial U.S. Approval: [1955]
Approved
Approval ID
281ab967-7565-4bef-9c0c-a646589c671e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2021
Manufacturers
FDA
Horizon Therapeutics USA, Inc.
DUNS: 033470838
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
prednisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75987-022
Application NumberNDA202020
Product Classification
M
Marketing Category
C73594
G
Generic Name
prednisone
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2021
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
PREDNISONEActive
Quantity: 5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
prednisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75987-021
Application NumberNDA202020
Product Classification
M
Marketing Category
C73594
G
Generic Name
prednisone
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2021
FDA Product Classification
INGREDIENTS (11)
PREDNISONEActive
Quantity: 2 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
prednisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code75987-020
Application NumberNDA202020
Product Classification
M
Marketing Category
C73594
G
Generic Name
prednisone
Product Specifications
Route of AdministrationORAL
Effective DateMay 24, 2021
FDA Product Classification
INGREDIENTS (11)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PREDNISONEActive
Quantity: 1 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT