Calcitriol
Calcitriol Capsules Rx only
Approved
Approval ID
97cf7807-3b48-403b-bae2-2fe585946e0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2022
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcitriol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-967
Application NumberANDA204556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcitriol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2022
FDA Product Classification
INGREDIENTS (17)
CALCITRIOLActive
Quantity: 0.25 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
Calcitriol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62756-968
Application NumberANDA204556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcitriol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2022
FDA Product Classification
INGREDIENTS (16)
CALCITRIOLActive
Quantity: 0.5 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT