FDA.reportPublic FDA data

PHYTONADIONE

Product NDC
0404-9935
11-digit product format
004049935
Labeler code
0404
Product ID
0404-9935_d8f4e356-c09c-4efe-961a-98a96174b73f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phytonadione
Dosage form
INJECTION, EMULSION
Route
PARENTERAL
Labeler
Henry Schein, Inc.
Application
ANDA083722
Marketing category
ANDA
Marketing start
2022-01-13
Substance
PHYTONADIONE
Active strength
1 mg/.5mL
Pharmacologic classes
Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHYTONADIONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHYTONADIONE1 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA034SE7857
Rxcui727625

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9935-05PHYTONADIONE1 in 1 BAGINJECTION, EMULSION15
0404-9935-05PHYTONADIONE1 in 1 BOXINJECTION, EMULSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9935PHYTONADIONE INJECTION, EMULSION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20240515_0d971993-466c-46dd-bdd6-2e300173621e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727625phytonadione 1 MG in 0.5 ML Prefilled SyringePSN0d971993-466c-46dd-bdd6-2e300173621e5
7276250.5 ML vitamin K1 2 MG/ML Prefilled SyringeSCD0d971993-466c-46dd-bdd6-2e300173621e5
7276250.5 ML phytonadione 2 MG/ML Prefilled SyringeSY0d971993-466c-46dd-bdd6-2e300173621e5
727625phytonadione 1 MG per 0.5 ML Prefilled SyringeSY0d971993-466c-46dd-bdd6-2e300173621e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9935-05004049935051 BOX in 1 BAG (0404-9935-05) / 1 SYRINGE in 1 BOX / .5 mL in 1 SYRINGE1 box2022-01-130000-00-00NoNoCurrent