Calcitriol
Calcitriol Capsules (0.25 mcg and 0.5 mcg)
Approved
Approval ID
bebefb2a-7365-48e2-9681-83ed4b41e26e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2022
Manufacturers
FDA
Strides Pharma Science Limited
DUNS: 650738743
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcitriol Capsules 0.25 mcg
PRODUCT DETAILS
NDC Product Code64380-723
Application NumberANDA091356
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 28, 2022
Generic NameCalcitriol Capsules 0.25 mcg
INGREDIENTS (9)
CALCITRIOLActive
Quantity: 0.25 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
NONCRYSTALLIZING SORBITOL SOLUTIONInactive
Code: 9E0S3UM200
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
Calcitriol Capsules 0.5 mcg
PRODUCT DETAILS
NDC Product Code64380-724
Application NumberANDA091356
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 28, 2022
Generic NameCalcitriol Capsules 0.5 mcg
INGREDIENTS (9)
CALCITRIOLActive
Quantity: 0.5 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
NONCRYSTALLIZING SORBITOL SOLUTIONInactive
Code: 9E0S3UM200
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT