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

CalcitriolCalcitriol INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0132
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)4 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)1.5 mg in 1 mL
SODIUM ASCORBATE(UNII: S033EH8359)10 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)7.6 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)1.8 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)1.1 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0132-2525 in 1 CARTON
11 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075746 03/14/2005

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

Carton