NDC Code(s) : 0517-0132-25
Packager : American Regent, Inc.
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL – 1 mL Carton
CALCITRIOL INJECTION
1 mcg/mL
NDC 0517-0132-25
25 x 1 mL Ampules
FOR INTRAVENOUS USE
Rx Only
Each mL contains: Calcitriol 1 mcg; Polysorbate 20, 4 mg; Sodium Chloride 1.5 mg; Sodium Ascorbate 10 mg added; Dibasic Sodium Phosphate, Anhydrous 7.6 mg; Monobasic Sodium Phosphate, Monohydrate 1.8 mg; Edetate Disodium, Dihydrate 1.1 mg added; Water for Injection q.s. pH range 6.7 to 7.7. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) (See USP Controlled RoomTemperature).
WARNING: Protect from light. Retain ampules in carton until time of use.
Directions for Use: See Package Insert.
AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
Rev. 11/05
