Phytonadione
These highlights do not include all the information needed to use PHYTONADIONE TABLETS safely and effectively. See full prescribing information for PHYTONADIONE TABLETS. PHYTONADIONE tablets, for oral useInitial U.S. Approval: 1955
Approved
Approval ID
63771c95-d4f5-42eb-b591-4df146f18cb0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Exelan Pharmaceuticals, Inc.
DUNS: 967795266
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 Code76282-740
Application NumberANDA213329
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phytonadione
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (8)
PHYTONADIONEActive
Quantity: 5 mg in 1 1
Code: A034SE7857
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT