FDA.reportPublic FDA data

Phytonadione

Manufacturer
Square Pharmaceuticals Ltd.
Effective date
2016-04-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:00:13

Label at a glance#

ProductPhytonadione
Active ingredientPHYTONADIONE
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10mg/mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10mg/mL
10mg/mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1mg/0.5 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1mg/0.5mL
1mg/0.5mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76483-051-312025-01-07C16284748780-19d75b9cf-f350-f424-e053-dadaa90a57ceRx only
76483-052-302025-01-07C16284748780-19d75b9cf-f350-f424-e053-dadaa90a57ceRx only
76483-051-312020-01-31C16284748780-19d75b9cf-f350-f424-e053-dadaa90a57ceRx only
76483-052-302020-01-31C16284748780-19d75b9cf-f350-f424-e053-dadaa90a57ceRx only

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76483-05176483-051-31
76483-05276483-052-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHYTONADIONEA034SE7857ACTIB
PHYTONADIONEA034SE7857ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b15a1de-8e18-9796-e063-6394a90a41f6fc034989-1fcb-43ed-9d62-815f3ba97d9d2025-01-06Exact identifier
spl set id: fc034989-1fcb-43ed-9d62-815f3ba97d9d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.