NDC Code(s) : 63323-311-19, 63323-311-59
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Calcium Gluconate CALCIUM GLUCONATE INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:63323-311-1925 in 1 TRAY
110 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
2NDC:63323-311-5925 in 1 TRAY
250 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/09/2000

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY - Calcium Gluconate 50 mL Single Use Vial Label

Calcium Gluconate Injection, USP 

10%  5 grams per 50 mL (100 mg per mL)

For direct slow intravenous injection or intravenous additive use only.
Preservative free.
50 mL
Single Use Vial

Rx only


vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Calcium Gluconate 50 mL Single Use Vial Tray Label

Calcium Gluconate Injection, USP 

10%  5 grams per 50 mL (100 mg per mL)

For direct slow intravenous injection or intravenous additive use only.
Preservative free.
25 x 50 mL
Single Use Vials

Rx only

vial