MedPath

MEPHYTON

MEPHYTON (PHYTONADIONE)TABLETSVitamin K

Approved
Approval ID

4150414d-ed40-4055-ab75-7e17627ce7c6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-168
Application NumberNDA010104
Product Classification
M
Marketing Category
C73594
G
Generic Name
phytonadione
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2007
FDA Product Classification

INGREDIENTS (8)

phytonadioneActive
Quantity: 5 mg in 1 1
Code: A034SE7857
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CALCIUM PHOSPHATEInactive
Code: 97Z1WI3NDX
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

MEPHYTON - FDA Drug Approval Details