NDC Code(s) : 61786-225-08
Packager : REMEDYREPACK 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:61786-225(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
CALCIUM SACCHARATE(UNII: 6AP9J91K4V)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-225-0810 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product16/03/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/16/2015 03/17/2017

PRINCIPAL DISPLAY PANEL

DRUG: Calcium Gluconate


GENERIC: CALCIUM GLUCONATE


DOSAGE: INJECTION, SOLUTION


ADMINSTRATION: INTRAVENOUS


NDC: 61786-225-08


ACTIVE INGREDIENT(S):

  • CALCIUM GLUCONATE 94mg in 1mL


INACTIVE INGREDIENT(S):

  • CALCIUM SACCHARATE
  • HYDROCHLORIC ACID
  • SODIUM HYDROXIDE


PACKAGING: 10 mL in 1 VIAL, SINGLE-DOSE




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