Phytonadione

Product NDC
52584-240
11-digit product format
525840240
Labeler code
52584
Product ID
52584-240_19c78682-1798-4ce4-a251-e5bdc57821df
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
2012-09-14
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
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-240-002020-01-31C16284748780-19d75b9d0-7006-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
52584-240-00Phytonadione1 in 1 BAGINJECTION, EMULSION12
52584-240-00Phytonadione1 in 1 CARTONINJECTION, EMULSION12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-240PHYTONADIONE INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]2Legacy NDC, 2 package rows20170120_c89a776d-7886-42fe-afcb-5842eb893c23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727625phytonadione 1 MG in 0.5 ML Prefilled SyringePSNc89a776d-7886-42fe-afcb-5842eb893c232
7276250.5 ML vitamin K1 2 MG/ML Prefilled SyringeSCDc89a776d-7886-42fe-afcb-5842eb893c232
7276250.5 ML phytonadione 2 MG/ML Prefilled SyringeSYc89a776d-7886-42fe-afcb-5842eb893c232
727625phytonadione 1 MG per 0.5 ML Prefilled SyringeSYc89a776d-7886-42fe-afcb-5842eb893c232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52584-240-00525840240001 in 1 BAGHistorical