NDC Code(s) : 0074-8110-31
Packager : AbbVie Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CalcijexCalcitriol INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0074-8110
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCITRIOL(UNII: FXC9231JVH)
(CALCITRIOL - UNII:FXC9231JVH)
CALCITRIOL1 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20(UNII: 7T1F30V5YH)
SODIUM ASCORBATE(UNII: S033EH8359)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ALUMINUM(UNII: CPD4NFA903)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0074-8110-315 in 1 CARTON
11 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018874 06/01/2010

PRINCIPAL DISPLAY PANEL

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