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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0339
Application NumberANDA091433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxercalciferol
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2017
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0388
Application NumberANDA091433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxercalciferol
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2017
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0338
Application NumberANDA091433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxercalciferol
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2017
FDA Product Classification
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