Vitamin K1 (Page 3 of 3)

Storage

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Keep ampuls in tray until time of use. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

PHYTONADIONE

Label ImageLabel Image
VITAMIN K1
phytonadione injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4521(NDC:0409-9158)
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL 70 mg in 1 mL
DEXTROSE MONOHYDRATE 37.5 mg in 1 mL
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4521-0 1 mL in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087955 07/27/2005
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4521), REPACK (50090-4521)

Revised: 10/2019 A-S Medication Solutions

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