Calcitriol
CALCITRIOL INJECTION, USP
Approved
Approval ID
f3b180dd-6c0b-4c15-85d3-bbbb5176d1d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2022
Manufacturers
FDA
Akorn
DUNS: 117693100
Products 1
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 Code17478-831
Application NumberANDA078066
Product Classification
M
Marketing Category
C73584
G
Generic Name
Calcitriol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 3, 2013
FDA Product Classification
INGREDIENTS (8)
CalcitriolActive
Quantity: 1 ug in 1 mL
Code: FXC9231JVH
Classification: ACTIB
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
Sodium AscorbateInactive
Code: S033EH8359
Classification: IACT
Sodium Phosphate, Monobasic, MonohydrateInactive
Code: 593YOG76RN
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT