Doxercalciferol
Doxercalciferol capsules, for oral use These highlights do not include all the information needed to use doxercalciferol capsules safely and effectively. See full prescribing information for doxercalciferol capsules. Doxercalciferol capsules, for oral use Initial U.S. Approval: 1999
Approved
Approval ID
356fb38a-791c-48f0-9312-6203ae57d80c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxercalciferol
PRODUCT DETAILS
NDC Product Code62135-452
Application NumberANDA205360
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2023
Generic NameDoxercalciferol
INGREDIENTS (10)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DOXERCALCIFEROLActive
Quantity: 2.5 ug in 1 1
Code: 3DIZ9LF5Y9
Classification: ACTIB
Doxercalciferol
PRODUCT DETAILS
NDC Product Code62135-451
Application NumberANDA205360
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2023
Generic NameDoxercalciferol
INGREDIENTS (11)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DOXERCALCIFEROLActive
Quantity: 1 ug in 1 1
Code: 3DIZ9LF5Y9
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Doxercalciferol
PRODUCT DETAILS
NDC Product Code62135-450
Application NumberANDA205360
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 30, 2023
Generic NameDoxercalciferol
INGREDIENTS (9)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DOXERCALCIFEROLActive
Quantity: 0.5 ug in 1 1
Code: 3DIZ9LF5Y9
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT