Calcitriol
Calcitriol Capsules
Approved
Approval ID
b1fef137-63c5-4662-8cd9-b9e8b12bacb6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcitriol
PRODUCT DETAILS
NDC Product Code65162-576
Application NumberANDA203289
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 18, 2023
Generic NameCalcitriol
INGREDIENTS (12)
CALCITRIOLActive
Quantity: 0.5 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
PROPYLPARABEN SODIUMInactive
Code: 625NNB0G9N
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Calcitriol
PRODUCT DETAILS
NDC Product Code65162-519
Application NumberANDA203289
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 18, 2023
Generic NameCalcitriol
INGREDIENTS (11)
CALCITRIOLActive
Quantity: 0.25 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLPARABEN SODIUMInactive
Code: 625NNB0G9N
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT