PHYTONADIONE- phytonadione injection, emulsion 
Square Pharmaceuticals Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10mg/mL

10mg/mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1mg/0.5 mL

1mg/0.5mL
PHYTONADIONE 
phytonadione injection, emulsion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-051
Route of AdministrationPARENTERAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE10 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76483-051-311 mL in 1 AMPULE; Type 0: Not a Combination Product04/10/201804/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/201804/10/2018
PHYTONADIONE 
phytonadione injection, emulsion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76483-052
Route of AdministrationPARENTERAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE1 mg  in 0.5 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76483-052-300.5 mL in 1 AMPULE; Type 0: Not a Combination Product04/10/201804/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/201804/10/2018
Labeler - Square Pharmaceuticals Ltd. (731487153)
Establishment
NameAddressID/FEIBusiness Operations
Square Pharmaceuticals Ltd.731487153analysis(76483-051, 76483-052) , label(76483-051, 76483-052) , manufacture(76483-051, 76483-052) , pack(76483-051, 76483-052)

Revised: 1/2025
Document Id: 2b15a1de-8e18-9796-e063-6394a90a41f6
Set id: fc034989-1fcb-43ed-9d62-815f3ba97d9d
Version: 2
Effective Time: 20250106
 
Square Pharmaceuticals Ltd.