CALCITRIOL
CALCITRIOL CAPSULES and ORAL SOLUTION Rx only
Approved
Approval ID
66a69351-5b09-4368-a9fa-acf81b5ad882
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2018
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CALCITRIOL
PRODUCT DETAILS
NDC Product Code63304-240
Application NumberNDA018044
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateAugust 22, 2018
Generic NameCALCITRIOL
INGREDIENTS (9)
CALCITRIOLActive
Quantity: 0.5 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CALCITRIOL
PRODUCT DETAILS
NDC Product Code63304-241
Application NumberNDA021068
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateAugust 22, 2018
Generic NameCALCITRIOL
INGREDIENTS (4)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CALCITRIOLActive
Quantity: 1 ug in 1 mL
Code: FXC9231JVH
Classification: ACTIB
PALM OILInactive
Code: 5QUO05548Z
Classification: IACT
CALCITRIOL
PRODUCT DETAILS
NDC Product Code63304-239
Application NumberNDA018044
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateAugust 22, 2018
Generic NameCALCITRIOL
INGREDIENTS (8)
CALCITRIOLActive
Quantity: 0.25 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT