SPL Set ID: 2ce1dd90-11ad-4f74-af16-45b7e59f05da

1 drug(s) with this SPL Set ID

Open DailyMed details

phytonadione PHYTONADIONE
1 mg/0.5 ml Injection
AMNEAL PHARMACEUTICALS LLC FDA Rx Only

Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, very viscous liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and in vegetable oils; slightly soluble in alcohol and insoluble in water. It has a molecular weight of 450.70 g/mol. Phytonadione is 2-Methyl-3-(3,7,11,15-tetramethylhexadec-2-en-1-yl)naphthalene-1,4-dione. Its molecular formula is C 31 H 46 O 2 and its molecular structure is: Phytonadione Injectable Emulsion, USP is a sterile, clear yellow color solution of vitamin K 1 , with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular and subcutaneous routes. Phytonadione injectable emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose prefilled glass syringe. Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains: Active: Phytonadione, USP (Vitamin K1)………………1 mg Inactive: Polysorbate 80 …………………………10 mg Propylene glycol ………………………10.4 mg Sodium acetate anhydrous.…………..…0.17 mg Glacial acetic acid .………….….….......0.00002 mL Water for injection.….…………………q.s. to 0.5 mL Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0. 1

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