Calcitriol
Calcitriol Capsules (0.25 mcg & 0.5 mcg)
Approved
Approval ID
c3d5546b-ccd4-4988-9d86-9f0b29e12128
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2017
Manufacturers
FDA
Atlantic Biologicals Corps
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Calcitriol 0.25 mcg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-0723
Application NumberANDA091356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcitriol 0.25 mcg
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2016
FDA Product Classification
INGREDIENTS (9)
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CALCITRIOLActive
Quantity: 0.25 ug in 1 1
Code: FXC9231JVH
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT