Phytonadione
These highlights do not include all the information needed to use PHYTONADIONE INJECTABLE EMULSION safely and effectively. See full prescribing information for PHYTONADIONE INJECTABLE EMULSION.PHYTONADIONE injectable emulsion, for intravenous, intramuscular, and subcutaneous use.Initial U.S. Approval: 1960
Approved
Approval ID
1add4de5-0f9c-453e-9dd5-abb8077b566a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 2
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 Code69097-709
Application NumberANDA214596
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phytonadione
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 11, 2024
FDA Product Classification
INGREDIENTS (6)
PHYTONADIONEActive
Quantity: 1 mg in 0.5 mL
Code: A034SE7857
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Phytonadione
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-708
Application NumberANDA214596
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phytonadione
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 11, 2024
FDA Product Classification
INGREDIENTS (6)
PHYTONADIONEActive
Quantity: 10 mg in 1 mL
Code: A034SE7857
Classification: ACTIB
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT