NDC Code(s) : 0517-6710-10
Packager : American Regent, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Calcium ChlorideCALCIUM CHLORIDE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-6710
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698) 		CALCIUM CHLORIDE100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-6710-1010 in 1 BOX 02/06/2018
110 mL in 1 VIAL, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209088 02/06/2018

LABELER - American Regent, Inc.(002033710)

Establishment
Name Address ID/FEI Business Operations
American Regent, Inc. 027223179 manufacture(0517-6710)

PRINCIPAL DISPLAY PANEL

NDC 0517-6710-01
Rx Only
10% Calcium Chloride Injection, USP
1 Gram/10 mL (100 mg/mL)
For Intravenous Use Only
Sterile, nonpyrogenic.
10 mL Single-dose Vial

Container Label

PRINCIPAL DISPLAY PANEL

NDC 0517-6710-10
Rx Only
10% Calcium Chloride Injection, USP
1 Gram/10 mL (100 mg/mL)
Represents 27 mg (1.4 mEq) Ca**/mL
For Intravenous Use Only
10 x 10 mL Single-dose Vials
American Regent, Inc.
Shirley, NY  11967

Carton Labeling