NDC Code(s) : 51662-1312-1
Packager : HF Acquisition Co LLC, DBA HealthFirst

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:51662-1312(NDC:63323-360)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE MONOHYDRATE(UNII: CZN0MI5R31)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM GLUCONATE MONOHYDRATE98 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:51662-1312-110 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product18/10/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208418 10/18/2018

LABELER - HF Acquisition Co LLC, DBA HealthFirst(045657305)

REGISTRANT - HF Acquisition Co LLC, DBA HealthFirst(045657305)

Establishment
Name Address ID/FEI Business Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel(51662-1312)

PRINCIPAL DISPLAY PANEL

VIAL LABEL

PRINCIPAL DISPLAY PANEL

RFID Label