NDC Code(s) : 55154-2388-5, 55154-2356-5
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Vitamin K1PHYTONADIONE INJECTION, EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-2388(NDC:0409-9157)
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE(UNII: A034SE7857)
(PHYTONADIONE - UNII:A034SE7857) 		PHYTONADIONE2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)70 mg in 1 mL
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)37.5 mg in 1 mL
WATER(UNII: 059QF0KO0R)
BENZYL ALCOHOL(UNII: LKG8494WBH)9 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-2388-55 in 1 BAG 24/08/2011
10.5 mL in 1 AMPULE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087954 08/24/2011
Vitamin K1PHYTONADIONE INJECTION, EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-2356(NDC:0409-9158)
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE(UNII: A034SE7857)
(PHYTONADIONE - UNII:A034SE7857) 		PHYTONADIONE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)70 mg in 1 mL
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)37.5 mg in 1 mL
WATER(UNII: 059QF0KO0R)
BENZYL ALCOHOL(UNII: LKG8494WBH)9 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-2356-55 in 1 BAG 24/08/2011
11 mL in 1 AMPULE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087955 08/24/2011 07/31/2013

PRINCIPAL DISPLAY PANEL

Vitamin K1 Injection 1 mg/0.5 mL

Phytonadione Injectable Emulsion, USP

Neonatal Concentration

5 x 0.5 mL Single-Dose Ampuls

bag label

PRINCIPAL DISPLAY PANEL

Vitamin K1 Injection 10 mg/mL

Phytonadione Injectable Emulsion, USP

5 x 1 mL Single-Dose Ampuls

bag label