PHYTONADIONE
Rx only
Approved
Approval ID
02445c07-7b4b-cd70-54e8-ebefc814f547
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 30, 2019
Manufacturers
FDA
Dr.Reddy's Laboratories Inc
DUNS: 802315887
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 Code43598-405
Application NumberANDA207719
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHYTONADIONE
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS
Effective DateMay 30, 2014
FDA Product Classification
INGREDIENTS (6)
PhytonadioneActive
Quantity: 10 mg in 1 mL
Code: A034SE7857
Classification: ACTIB
Polyoxyl 35 Castor OilInactive
Quantity: 70 mg in 1 mL
Code: 6D4M1DAL6O
Classification: IACT
Benzyl AlcoholInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
Dextrose MonohydrateInactive
Quantity: 37.5 mg in 1 mL
Code: LX22YL083G
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT