NDC Code(s) : 55154-9370-5, 55154-9370-8
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Calcium GluconateCALCIUM GLUCONATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-9370(NDC:63323-311)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE(UNII: SQE6VB453K)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM GLUCONATE94 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CALCIUM SACCHARATE(UNII: 6AP9J91K4V)4.5 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-9370-55 in 1 BAG
110 mL in 1 VIAL, SINGLE-DOSE
2NDC:55154-9370-81 in 1 BAG
210 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/09/2000

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY

Calcium Gluconate Injection,

USP 10% (100 mg/mL)

5 x 10 ML Single Dose Vials

Bag Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY

Calcium Gluconate Injection,

USP 10% (100 mg/mL)

1 x 10 ML Single Dose Vials

Bag Label