NDC 52584-311-59
API & Excipient Details

marketed by General Injectables & Vaccines, Inc. under NDC Code 52584-311-59

NDC Code(s) : 52584-311-19, 52584-311-59
Packager : General Injectables & Vaccines, Inc.

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:52584-311(NDC:63323-311)
Route of Administration	INTRAVENOUS	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALCIUM GLUCONATE(UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM GLUCONATE	94 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CALCIUM SACCHARATE(UNII: 6AP9J91K4V)	4.5 mg in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52584-311-19	1 in 1 BAG	11/06/2015
1		10 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2	NDC:52584-311-59	1 in 1 BAG	11/06/2015
2		50 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/11/2015

PRINCIPAL DISPLAY PANEL