Label: PHYTONADIONE injection, emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 76483-051-31, 76483-052-30 - Packager: Square Pharmaceuticals Ltd.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated April 28, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10mg/mL
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1mg/0.5 mL
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INGREDIENTS AND APPEARANCE
PHYTONADIONE
phytonadione injection, emulsionProduct 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, emulsionProduct 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)
