PHYTONADIONE injection, emulsion

Phytonadione by

Drug Labeling and Warnings

Phytonadione by is a Prescription medication manufactured, distributed, or labeled by Square Pharmaceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10mg/mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1mg/0.5 mL

INGREDIENTS AND APPEARANCE

PHYTONADIONE 
phytonadione injection, emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76483-051
Route of Administration	PARENTERAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)	PHYTONADIONE	10 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76483-051-31	1 mL in 1 AMPULE; Type 0: Not a Combination Product	04/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/10/2018

PHYTONADIONE 
phytonadione injection, emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 76483-052
Route of Administration	PARENTERAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)	PHYTONADIONE	1 mg  in 0.5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76483-052-30	0.5 mL in 1 AMPULE; Type 0: Not a Combination Product	04/10/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/10/2018

Labeler - Square Pharmaceuticals Ltd. (731487153)

Establishment
Name	Address	ID/FEI	Business Operations
Square Pharmaceuticals Ltd.		731487153	analysis(76483-051, 76483-052) , label(76483-051, 76483-052) , manufacture(76483-051, 76483-052) , pack(76483-051, 76483-052)