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
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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)