Phytonadione
PHYTONADIONE INJECTABLE EMULSION, USPAqueous Colloidal Solution of Vitamin K1Rx Only
Approved
Approval ID
c89a776d-7886-42fe-afcb-5842eb893c23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2017
Manufacturers
FDA
General Injectables & Vaccines, Inc
DUNS: 108250663
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phytonadione
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52584-240
Application NumberANDA083722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phytonadione
Product Specifications
Route of AdministrationPARENTERAL
Effective DateJanuary 12, 2017
FDA Product Classification
INGREDIENTS (6)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHYTONADIONEActive
Quantity: 1 mg in 0.5 mL
Code: A034SE7857
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT