PHYTONADIONE

Product NDC
52584-043
11-digit product format
525840043
Labeler code
52584
Product ID
52584-043_9f57b5ad-5b9c-4a8a-9989-02727fcf824c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phytonadione
Dosage form
INJECTION, EMULSION
Route
PARENTERAL
Labeler
General Injectables & Vaccines, Inc
Application
ANDA083722
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-043-052020-01-31C16284748780-19d75b9d0-c7fc-f424-e053-dadaa90a57cePHYTONADIONE INJECTABLE EMULSION, USP Aqueous Colloidal Solution of Vitamin K1 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52584-043-05PHYTONADIONE1 in 1 CARTONINJECTION, EMULSION12
52584-043-05PHYTONADIONE1 in 1 BAGINJECTION, EMULSION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHYTONADIONEACTIVE INGREDIENTA034SE7857PHYTONADIONE INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]1
PHYTONADIONEACTIVE MOIETYA034SE7857PHYTONADIONE INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-043PHYTONADIONE INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]2Legacy NDC, 2 package rows20170120_4a4e56d0-b466-42d5-91ef-f4a33409bbc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727625phytonadione 1 MG in 0.5 ML Prefilled SyringePSN4a4e56d0-b466-42d5-91ef-f4a33409bbc52
7276250.5 ML vitamin K1 2 MG/ML Prefilled SyringeSCD4a4e56d0-b466-42d5-91ef-f4a33409bbc52
7276250.5 ML phytonadione 2 MG/ML Prefilled SyringeSY4a4e56d0-b466-42d5-91ef-f4a33409bbc52
727625phytonadione 1 MG per 0.5 ML Prefilled SyringeSY4a4e56d0-b466-42d5-91ef-f4a33409bbc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52584-043-05525840043051 in 1 CARTONHistorical