Doxercalciferol
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 useInitial U.S. Approval: 1999
Approved
Approval ID
1bb3ce2f-c77a-436f-980f-a02668f99fed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 25, 2019
Manufacturers
FDA
West-Ward Pharmaceuticals Corp.
DUNS: 080189610
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 Code0054-0339
Application NumberANDA091433
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 25, 2017
Generic NameDoxercalciferol
INGREDIENTS (15)
DOXERCALCIFEROLActive
Quantity: 2.5 ug in 1 1
Code: 3DIZ9LF5Y9
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Doxercalciferol
PRODUCT DETAILS
NDC Product Code0054-0388
Application NumberANDA091433
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 25, 2017
Generic NameDoxercalciferol
INGREDIENTS (15)
DOXERCALCIFEROLActive
Quantity: 1 ug in 1 1
Code: 3DIZ9LF5Y9
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Doxercalciferol
PRODUCT DETAILS
NDC Product Code0054-0338
Application NumberANDA091433
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 25, 2017
Generic NameDoxercalciferol
INGREDIENTS (16)
DOXERCALCIFEROLActive
Quantity: 0.5 ug in 1 1
Code: 3DIZ9LF5Y9
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT